Choroid Plexus TumorsPhase 3NCT00500890
Treatment of Tumors of the Choroid Plexus Epithelium
A Phase 3 study testing Carboplatin, Cyclophosphamide and Etoposide in people with Choroid Plexus Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to compare carboplatin to cyclophosphamide when given with etoposide, vincristine, and radiation therapy in the treatment of choroid plexus tumors. The safety of these 2 combination therapies will also be compared. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Choroid Plexus Tumors
- What is being tested?
- Carboplatin, Cyclophosphamide and Etoposide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2005to 14 Dec 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The reference center has confirmed the receipt of slides sent (For randomization only = form 2)
- The postoperative imaging has been done and the result is available (for randomization only = for form 2 only)
- Indication criteria: Choroid plexus papilloma (Gr I) with histologically confirmed metastases. (For randomization only = use form 2).
- Indication criteria: Atypical choroid plexus papilloma or anaplastic choroid plexus papilloma histology with either metastases or postoperative residual tumor. (For randomization only = use form 2).
- Indication criteria: Choroid plexus carcinoma, regardless of histologically confirmed metastases or residual tumor. (For randomization only = use form 2).
- Informed consent signed (required for registration = form 1, and for randomization = form 2)
- Patients must have the following: WBC > 2000/ul, platelets >85 000/ul, serum creatinine in normal range, pregnancy test negative, hearing loss less than 30dB at 3000 Hz.
Who cannot join
- Previous irradiation or chemotherapy. (Exclusion from randomization only)
- The protocol did not pass the local centre required approvals, such as the Ethics Committee or the scientific review.
- Previous immunotherapy or antiangiogenic therapy (Exclusion from randomization only)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Pilot Study Evaluating the Feasibility of an Intercontinental Phase III Chemotherapy Study for Patients With Choroid Plexus Tumors
The goal of this clinical research study is to compare carboplatin to cyclophosphamide when given with etoposide, vincristine, and radiation therapy in the treatment of choroid plexus tumors. The safety of these 2 combination therapies will also be compared.
Objectives:
Read more
OVERALL AIM:
To improve choroid plexus tumor treatment through better understanding of the tumor biology and through increased knowledge about the benefit of specific treatment elements.
Specific Objectives:
The study will have a prephase to evaluate the feasibility of the following randomized study (main phase).
Pre-Phase (completed 2005) Primary Specific Objective:
To determine the number of patients accountable per year for randomization in a worldwide study.
Secondary Specific Objective:
To measure the number of drop outs and to describe the toxicity of the chemotherapy.
Main Phase (started in 2006) Primary Specific Objective:
To compare the survival times after cyclophosphamide based treatment with the survival times after carboplatin based treatment in choroid plexus tumor patients.
Main Phase Secondary Specific Objectives:
- To compare the resectability of choroid plexus tumors after two blocks of cyclophosphamide based treatment with the resectability after two blocks of carboplatin based treatment.
- To compare response rates of incompletely resected choroid plexus tumors to two blocks of cyclophosphamide based treatment with the response rates after two blocks of carboplatin based treatment.
- To determine the prognostic relevance of histological atypia and SV40 in choroid plexus tumors.
Read the detailed description
Tumors of the choroid plexus epithelium are rare. Participants in this study will have surgery to remove as much of the brain tumor as possible. Taking as much of the tumor out during surgery is generally believed to have the best result for this disease. Some participants may even have a second surgery to remove more tumor if thought necessary.
After the tumor surgery, exact treatment for each participant in this study will depend on how much of the tumor is removed during surgery and the way the tumor tissue looks under a microscope. Some participants will not require additional treatment because most or all of the tumor has been taken out. Those participants will still be on study, but they will only have observation and not receive additional treatment. Those that require additional treatment will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups with an equal chance of being assigned to either group.
Chemotherapy (treatment with anti-cancer drugs) will be given as part of treatment for participants whose tumors are not completely removed surgically. Participants in one group will receive carboplatin plus etoposide, vincristine, and radiation therapy . Participants in the other group will receive cyclophosphamide plus etoposide, vincristine, and radiation therapy. Among all the known drugs for cancer, etoposide, vincristine, cyclophosphamide, and platinum drugs are the most effective against brain tumors. Carboplatin will be used because fewer side effects related to hearing should occur later on. This study also uses radiation therapy after surgery for children younger than 3 years old. Normally, chemotherapy has been used to delay radiation therapy until the child was older because of concerns about side effects. This change has been made because of the poor results achieved when chemotherapy was used to delay radiation therapy.
Chemotherapy is the one and only additional treatment that participants under 3 years of age can receive in this study. After the first 2 cycles, response will be evaluated, including all exams done at screening before you continue on treatment, if needed. Further surgery will be considered after these exams. If both you and your doctor choose to consider further surgery and agree for the procedure to be the next appropriate step, you may undergo a second surgery to remove anymore remaining tumor. After the second surgery, the chemotherapy will be again continued on the same schedule for 4 more cycles. If you did not require further surgery, you will continue on with the chemotherapy as previously planned.
For participants older than 3 years of age, radiation therapy will be a part of the treatment. It will be given after the second cycle of chemotherapy. Participants will receive radiation once per day, five days per week, over a period of about 6 weeks. Most of the participants do not need to stay in the hospital during this time. This will be followed by 6 more cycles of chemotherapy. After 6 cycles of chemotherapy, further surgery will again be considered. While on radiation treatment, you will have blood (about 2 teaspoons) drawn for routine tests 2 times a week. Before and after the finish of radiation, another blood test (2-3 teaspoons) will be taken to monitor the kidney and liver function, as well as to measure levels of hormones. You will have a physical exam, and blood (about 2 teaspoons) will be drawn for routine tests before each cycle of treatment.
Participants in the carboplatin group will receive etoposide over 1 hour on Days 1-5, carboplatin over 2 hours on Days 2 and 3, and vincristine over 15 minutes on Day 5. This will be repeated every 4 weeks for 24 weeks. Each period of 4 weeks is considered 1 cycle of treatment.
Participants in the cyclophosphamide group will receive etoposide over 1 hour on Days 1-5, cyclophosphamide over 1 hour on Days 2 and 3, and vincristine over 15 minutes on Day 5. This will be repeated every 4 weeks for 6 cycles (24 weeks) of treatment. Mesna, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide.
The chemotherapy given in this study can cause your white blood cell count to be too low. White blood cells are infection-fighting cells. If the white blood cell count is low for too long, participants in both groups may be given a drug called G-CSF (filgrastim). Filgrastim is a growth factor naturally produced in the body to increase the production of white blood cells. Filgrastim will be given as a shot under the skin starting at Day 9 after starting the chemotherapy.
The total length of treatment that you can receive will be 7 months, if you are able to complete all the cycles of the additional treatment. You will be taken off study if the disease gets worse or intolerable side effects occur, and your doctor will discuss other treatment options with you.
After completing treatment, there will be follow-up visits every 3 months for the first year. Every 6 months there will still be visits with the doctor until 4 years after completing treatment. You will continue to have follow-up visits every year after that to monitor for any signs of the disease coming back, or for as long as you would agree to allow follow-up visits. At each visit, you will have routine blood tests (about 2-3 teaspoons), checking of hormone levels, measurement of growth, and a hearing test. The effects of radiation/chemotherapy on your brain function, your ability to learn, and your quality of life will be measured. You will have a MRI of the brain, all known metastatic sites, and of the spine. Your body height and body weight will be measured. About 2 teaspoons of blood will be drawn for routine tests. Your urine will be tested for the presence of blood. You will have a spinal tap to look for cancer cells in the spinal fluid. Your hormone levels will also be taken to see if there are any signs of metabolic disorder and growth deficiency. This will be done with the other blood test and will not require any more extra blood samples from you.
This is an investigational study. All of the drugs used in this study are FDA approved and are commercially available. Their use together in this study is experimental. A total of up to 100 patients will take part in this multicenter study. Up to 5 will be enrolled here at M. D. Anderson.
- Conditions
- Choroid Plexus Tumors
- Being tested
- Carboplatin, Cyclophosphamide, Etoposide, Vincristine, Radiation Therapy
- Keywords
- Choroid Plexus Tumors, Carboplatin, Cyclophosphamide, Etoposide, Vincristine, Paraplatin, Cytoxan, Neosar
- Medical subject headings
- Choroid Plexus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Paraplatin
350 mg/m^2 by vein, Over 2 Hours x 2 Days
CyclophosphamideDrug
Also called Cytoxan, Neosar
1 g/m^2 by vein, Over 1 Hour x 2 Days
EtoposideDrug
100 mg/m^2 by vein, Over 1 Hour x 5 Days
VincristineDrug
1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5
Radiation TherapyRadiation
Also called RT, XRT, Radiotherapy
Radiation treatment over a period of about 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin + Etoposide + Vincristine | Experimental | Carboplatin 350 mg/m^2 by vein, Over 2 Hours x 2 Days. Etoposide 100 mg/m^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks. Receives: Drug: Carboplatin; Drug: Etoposide; Drug: Vincristine; Radiation: Radiation Therapy |
| Cyclophosphamide + Etoposide + Vincristine | Experimental | Cyclophosphamide 1 g/m^2 by vein, Over 1 Hour x 2 Days. Etoposide 100 mg/m^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks. Receives: Drug: Cyclophosphamide; Drug: Etoposide; Drug: Vincristine; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Phase (Started in 2006) Primary Specific Objective
To compare the survival times after cyclophosphamide based treatment with survival times after carboplatin based treatment in chroid plexus tumors patients. For analysis, there will be no difference between death by tumor progression, treatment related (toxic) reasons or unrelated reasons.
Measured: After randomization until the end of the observation or the death of the patient
Secondary Objective SV40
To determine the prognostic relevance of histological atypia and SV40 in choroid plexus tumors. Prognosis of tumors with or without SV40 will be compared using overall survival time as endpoint. Kaplan Meier survival estimates and log rank tests as statistical methods similar to the analysis of primary objective.
Measured: No data were collected due to early termination
Secondary outcomes (2)
Secondary Objective Resectability
To compare the resectability of choroid plexus tumors after two blocks of cyclophosphamide based therapy treatment with the resectability after two blocks of carboplatin based treatment. Success of surgery after first 2 cycles of chemotherapy will be compared between two treatment arms. Percentage of patients with secondary complete remission from those with incomplete primary resection, will be used to analyze question. Tumor with CR and tumors which could be completely resected after two cycles of chemotherapy will be counted together. Frequency will be compared a month the 2 treatment arms using Chi-square test.
Measured: No data were collected due to early termination
Secondary Objective Response
To compare response rates of incompletely resected choroid plexus tumors to two blocks of cyclophosphamide based therapy treatment with the response rates after two blocks of carboplatin based treatment.
Measured: No data were collected due to early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study start2 Sep 2005
- Primary completion14 Dec 2017
- Study completion14 Dec 2017
Why it stopped: PI has left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Choroid Plexus TumorsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael E. Rytting, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500890
- Sponsor's protocol ID
- 2005-0398
- Other IDs
- NCI-2012-01568
- Status last verified
- Feb 2020
- First submitted
- 11 Jul 2007
- Last updated
- 27 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wrede B, Hasselblatt M, Peters O, Thall PF, Kutluk T, Moghrabi A, Mahajan A, Rutkowski S, Diez B, Wang X, Pietsch T, Kortmann RD, Paulus W, Jeibmann A, Wolff JEA. Atypical choroid plexus papilloma: clinical experience in the CPT-SIOP-2000 study. J Neurooncol. 2009 Dec;95(3):383-392. doi: 10.1007/s11060-009-9936-y. Epub 2009 Jun 20.
PubMed 19543851
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Feasibility of an Intercontinental Phase III Chemotherapy Study for Patients With Choroid Plexus Tumors
- ClinicalTrials.gov ID
- NCT00500890
- Acronym / sponsor ID
- 2005-0398
- Conditions
- Choroid Plexus Tumors
- Keywords
- Choroid Plexus Tumors, Carboplatin, Cyclophosphamide, Etoposide, Vincristine, Paraplatin, Cytoxan, Neosar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI has left the institution
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Sep 2005 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 13 Jul 2007 (estimated)
- Results
- Posted 27 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to compare carboplatin to cyclophosphamide when given with etoposide, vincristine, and radiation therapy in the treatment of choroid plexus tumors. The safety of these 2 combination therapies will also be compared.
Objectives:
OVERALL AIM:
To improve choroid plexus tumor treatment through better understanding of the tumor biology and through increased knowledge about the benefit of specific treatment elements.
Specific Objectives:
The study will have a prephase to evaluate the feasibility of the following randomized study (main phase).
Pre-Phase (completed 2005) Primary Specific Objective:
To determine the number of patients accountable per year for randomization in a worldwide study.
Secondary Specific Objective:
To measure the number of drop outs and to describe the toxicity of the chemotherapy.
Main Phase (started in 2006) Primary Specific Objective:
To compare the survival times after cyclophosphamide based treatment with the survival times after carboplatin based treatment in choroid plexus tumor patients.
Main Phase Secondary Specific Objectives:
- To compare the resectability of choroid plexus tumors after two blocks of cyclophosphamide based treatment with the resectability after two blocks of carboplatin based treatment.
- To compare response rates of incompletely resected choroid plexus tumors to two blocks of cyclophosphamide based treatment with the response rates after two blocks of carboplatin based treatment.
- To determine the prognostic relevance of histological atypia and SV40 in choroid plexus tumors.
Detailed description
Tumors of the choroid plexus epithelium are rare. Participants in this study will have surgery to remove as much of the brain tumor as possible. Taking as much of the tumor out during surgery is generally believed to have the best result for this disease. Some participants may even have a second surgery to remove more tumor if thought necessary.
After the tumor surgery, exact treatment for each participant in this study will depend on how much of the tumor is removed during surgery and the way the tumor tissue looks under a microscope. Some participants will not require additional treatment because most or all of the tumor has been taken out. Those participants will still be on study, but they will only have observation and not receive additional treatment. Those that require additional treatment will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups with an equal chance of being assigned to either group.
Chemotherapy (treatment with anti-cancer drugs) will be given as part of treatment for participants whose tumors are not completely removed surgically. Participants in one group will receive carboplatin plus etoposide, vincristine, and radiation therapy . Participants in the other group will receive cyclophosphamide plus etoposide, vincristine, and radiation therapy. Among all the known drugs for cancer, etoposide, vincristine, cyclophosphamide, and platinum drugs are the most effective against brain tumors. Carboplatin will be used because fewer side effects related to hearing should occur later on. This study also uses radiation therapy after surgery for children younger than 3 years old. Normally, chemotherapy has been used to delay radiation therapy until the child was older because of concerns about side effects. This change has been made because of the poor results achieved when chemotherapy was used to delay radiation therapy.
Chemotherapy is the one and only additional treatment that participants under 3 years of age can receive in this study. After the first 2 cycles, response will be evaluated, including all exams done at screening before you continue on treatment, if needed. Further surgery will be considered after these exams. If both you and your doctor choose to consider further surgery and agree for the procedure to be the next appropriate step, you may undergo a second surgery to remove anymore remaining tumor. After the second surgery, the chemotherapy will be again continued on the same schedule for 4 more cycles. If you did not require further surgery, you will continue on with the chemotherapy as previously planned.
For participants older than 3 years of age, radiation therapy will be a part of the treatment. It will be given after the second cycle of chemotherapy. Participants will receive radiation once per day, five days per week, over a period of about 6 weeks. Most of the participants do not need to stay in the hospital during this time. This will be followed by 6 more cycles of chemotherapy. After 6 cycles of chemotherapy, further surgery will again be considered. While on radiation treatment, you will have blood (about 2 teaspoons) drawn for routine tests 2 times a week. Before and after the finish of radiation, another blood test (2-3 teaspoons) will be taken to monitor the kidney and liver function, as well as to measure levels of hormones. You will have a physical exam, and blood (about 2 teaspoons) will be drawn for routine tests before each cycle of treatment.
Participants in the carboplatin group will receive etoposide over 1 hour on Days 1-5, carboplatin over 2 hours on Days 2 and 3, and vincristine over 15 minutes on Day 5. This will be repeated every 4 weeks for 24 weeks. Each period of 4 weeks is considered 1 cycle of treatment.
Participants in the cyclophosphamide group will receive etoposide over 1 hour on Days 1-5, cyclophosphamide over 1 hour on Days 2 and 3, and vincristine over 15 minutes on Day 5. This will be repeated every 4 weeks for 6 cycles (24 weeks) of treatment. Mesna, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide.
The chemotherapy given in this study can cause your white blood cell count to be too low. White blood cells are infection-fighting cells. If the white blood cell count is low for too long, participants in both groups may be given a drug called G-CSF (filgrastim). Filgrastim is a growth factor naturally produced in the body to increase the production of white blood cells. Filgrastim will be given as a shot under the skin starting at Day 9 after starting the chemotherapy.
The total length of treatment that you can receive will be 7 months, if you are able to complete all the cycles of the additional treatment. You will be taken off study if the disease gets worse or intolerable side effects occur, and your doctor will discuss other treatment options with you.
After completing treatment, there will be follow-up visits every 3 months for the first year. Every 6 months there will still be visits with the doctor until 4 years after completing treatment. You will continue to have follow-up visits every year after that to monitor for any signs of the disease coming back, or for as long as you would agree to allow follow-up visits. At each visit, you will have routine blood tests (about 2-3 teaspoons), checking of hormone levels, measurement of growth, and a hearing test. The effects of radiation/chemotherapy on your brain function, your ability to learn, and your quality of life will be measured. You will have a MRI of the brain, all known metastatic sites, and of the spine. Your body height and body weight will be measured. About 2 teaspoons of blood will be drawn for routine tests. Your urine will be tested for the presence of blood. You will have a spinal tap to look for cancer cells in the spinal fluid. Your hormone levels will also be taken to see if there are any signs of metabolic disorder and growth deficiency. This will be done with the other blood test and will not require any more extra blood samples from you.
This is an investigational study. All of the drugs used in this study are FDA approved and are commercially available. Their use together in this study is experimental. A total of up to 100 patients will take part in this multicenter study. Up to 5 will be enrolled here at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carboplatin + Etoposide + Vincristine | Experimental | Drug: Carboplatin, Drug: Etoposide, Drug: Vincristine, Radiation: Radiation TherapyCarboplatin 350 mg/m^2 by vein, Over 2 Hours x 2 Days. Etoposide 100 mg/m^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks. |
| Cyclophosphamide + Etoposide + Vincristine | Experimental | Drug: Cyclophosphamide, Drug: Etoposide, Drug: Vincristine, Radiation: Radiation TherapyCyclophosphamide 1 g/m^2 by vein, Over 1 Hour x 2 Days. Etoposide 100 mg/m^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- The reference center has confirmed the receipt of slides sent (For randomization only = form 2)
- The postoperative imaging has been done and the result is available (for randomization only = for form 2 only)
- Indication criteria: Choroid plexus papilloma (Gr I) with histologically confirmed metastases. (For randomization only = use form 2).
- Indication criteria: Atypical choroid plexus papilloma or anaplastic choroid plexus papilloma histology with either metastases or postoperative residual tumor. (For randomization only = use form 2).
- Indication criteria: Choroid plexus carcinoma, regardless of histologically confirmed metastases or residual tumor. (For randomization only = use form 2).
Key exclusion criteria (3 listed)
- Previous irradiation or chemotherapy. (Exclusion from randomization only)
- The protocol did not pass the local centre required approvals, such as the Ethics Committee or the scientific review.
- Previous immunotherapy or antiangiogenic therapy (Exclusion from randomization only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinAlso: Paraplatin350 mg/m^2 by vein, Over 2 Hours x 2 Days | Drug | Carboplatin + Etoposide + Vincristine |
| CyclophosphamideAlso: Cytoxan, Neosar1 g/m^2 by vein, Over 1 Hour x 2 Days | Drug | Cyclophosphamide + Etoposide + Vincristine |
| Etoposide100 mg/m^2 by vein, Over 1 Hour x 5 Days | Drug | Carboplatin + Etoposide + Vincristine, Cyclophosphamide + Etoposide + Vincristine |
| Vincristine1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5 | Drug | Carboplatin + Etoposide + Vincristine, Cyclophosphamide + Etoposide + Vincristine |
| Radiation TherapyAlso: RT, XRT, RadiotherapyRadiation treatment over a period of about 6 weeks. | Radiation | Carboplatin + Etoposide + Vincristine, Cyclophosphamide + Etoposide + Vincristine |
Primary outcome
Main Phase (Started in 2006) Primary Specific Objective
Time frame: After randomization until the end of the observation or the death of the patient
To compare the survival times after cyclophosphamide based treatment with survival times after carboplatin based treatment in chroid plexus tumors patients. For analysis, there will be no difference between death by tumor progression, treatment related (toxic) reasons or unrelated reasons.
Secondary Objective SV40
Time frame: No data were collected due to early termination
To determine the prognostic relevance of histological atypia and SV40 in choroid plexus tumors. Prognosis of tumors with or without SV40 will be compared using overall survival time as endpoint. Kaplan Meier survival estimates and log rank tests as statistical methods similar to the analysis of primary objective.
2 secondary outcomes
Secondary Objective Resectability
Time frame: No data were collected due to early termination
Secondary Objective Response
Time frame: No data were collected due to early termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19543851Wrede B, Hasselblatt M, Peters O, Thall PF, Kutluk T, Moghrabi A, Mahajan A, Rutkowski S, Diez B, Wang X, Pietsch T, Kortmann RD, Paulus W, Jeibmann A, Wolff JEA. Atypical choroid plexus papilloma: clinical experience in the CPT-SIOP-2000 study. J Neurooncol. 2009 Dec;95(3):383-392. doi: 10.1007/s11060-009-9936-y. Epub 2009 Jun 20.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael E. Rytting, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carboplatin, Cyclophosphamide and Etoposide in people with Choroid Plexus Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Phase (Started in 2006) Primary Specific Objective (time frame: After randomization until the end of the observation or the death of the patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.