MelanomaPhase 1BCAANCT00970996
Cisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma
A Phase 1 study testing Temozolomide, Abraxane and Cisplatin in people with Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given in combination with cisplatin, Temodar (temozolomide), interferon alfa-2b, and interleukin-2 (IL-2) to patients with metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Temozolomide, Abraxane and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III melanoma are eligible.
- They should have recurrent melanoma with measurable or evaluable sites of disease, 1.0 cm or larger, in order to assess the response to treatment by RECIST.
- They should not have been exposed to any previous chemotherapy or isolation perfusion for malignant melanoma and have had no previous exposure to interleukin-2. Prior adjuvant interferon is permitted.Prior radiation therapy for metastatic melanoma is permitted provided the patient has un-irradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
- Patients between 18 years of age and 65 years of age with an expected survival greater than 8 weeks and a Karnofsky performance status of 50% or better or an ECOG performance status of 0, 1 or 2 will be eligible.
- They should have normal blood counts with a WBC count of more than or equal to 3000/mm^3 an absolute neutrophil count of more than or equal to 1500/mm^3 and a platelet count of more than 100,000/mm^3 and have no impairment of renal function (serum creatinine less than 1.1 mg/dl for females and less than 1.4 mg/dl for males), hepatic function (serum bilirubin level of less than 1.2 mg/dl) and no evidence of significant cardiac or pulmonary dysfunction.
- They should have no significant intercurrent illness such as an active infection, uncontrolled psychiatric illness, hypercalcemia (calcium greater than 11 mg), or active GI bleeding.
Who cannot join
- Patients with bone metastases only.
- Patients with brain metastases unless their disease has been resected and they are off corticosteroids. Patients with spinal cord compression and leptomeningeal disease. No major surgery or radiation therapy within 21 days before starting treatment.
- Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (EF less than 55%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy. Patients with an EKG disclosing an absolute QT interval greater than 460 msec in the presence of serum potassium greater than or equal 4.0 mEq/L and magnesium greater than/=1.8 mg/dL.
- Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of FEV1 to less than 75% of predicted normal values.
- Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma.
- Patients who are unable to stay in Houston to receive therapy (first cycle) and/or unable to return for follow-up visits as required by this study.
- Patients with a history of second malignant tumor, other than the common skin cancers - basal and squamous carcinomas, within the past 5 years and uncertainty about the histological nature of the metastatic lesions.
- Patients with history of DVT or PE are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I Biochemotherapy With Cisplatin, Temozolomide, With Increasing Doses of Abraxane, Combined With Interleukin-2 and Interferon in Patients With Metastatic Melanoma
The goal of this clinical research study is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given in combination with cisplatin, Temodar (temozolomide), interferon alfa-2b, and interleukin-2 (IL-2) to patients with metastatic melanoma.
Primary Objective:
Read more
- The primary objective of the Phase I is to determine the toxicity, safety and the maximum tolerated dose maximum tolerated dose of Abraxane in combination with Cisplatin, Temozolomide, interleukin-2 and interferon a2b in patients with metastatic melanoma.
Secondary Objectives:
- To assess responses to the combination.
- To evaluate the duration of response and the overall survival.
- To determine the effectiveness in delaying the appearance of Central Nervous System disease.
Read the detailed description
The Study Drugs:
Cisplatin, nab-paclitaxel, and temozolomide are chemotherapy drugs and have a direct effect on melanoma cells. Interferon alfa-2b and IL-2 are biotherapy drugs that stimulate the immune system to fight against melanoma. The combination of chemotherapy and biotherapy drugs is called biochemotherapy.
This is the first study using these drugs in combination.
Catheter:
If you are found to be eligible to take part in this study, you will have a central venous catheter (CVC) inserted, if you do not already have one. The catheter is passed through the veins of your arm or the veins that run under your collar bone to reach a wide central vein in the chest that runs above your heart. You will receive a separate consent form for this procedure, which describes the risks.
Nab-paclitaxel, cisplatin, and interleukin-2 are given through this catheter. In certain situations, blood can also be drawn from this catheter.
Study Drug Dose Levels:
You will be assigned to a dose level of nab-paclitaxel based on when you joined this study. Up to 3 dose levels of nab-paclitaxel will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of nab-paclitaxel that can be given in combination with the other drugs is found.
All participants will receive the same dose level of temozolomide, cisplatin, interferon alfa-2b, and IL-2.
Study Drug Administration:
Each study cycle will last 3-5 weeks. The length of each cycle will depend on your recovery from the study drugs.
On Day 1 of each cycle:
- You will take temozolomide by mouth.
- You will receive nab-paclitaxel over about 30 minutes by vein about 1 hour after you take temozolomide.
- You will then receive cisplatin by vein. Each infusion of cisplatin will take about 45-120 minutes.
- You will receive interferon alfa-2b by injection into fatty tissue.
- You will begin your IL-2 infusion. The infusion will begin after you receive cisplatin and will continue non-stop until Day 5.
On Day 2 of each cycle:
- You will take temozolomide by mouth.
- You will receive cisplatin by vein about 1 hour after you take temozolomide.
- You will receive interferon alfa-2b by injection into fatty tissue.
On Day 3 of each cycle:
- You will take temozolomide by mouth.
- You will receive cisplatin by vein about 1 hour after you take temozolomide.
- You will receive interferon alfa-2b by injection into fatty tissue.
- Blood (up to 4 teaspoons total) will be drawn for routine tests and tests to check for infection in the blood.
On Day 4 of each cycle:
- You will receive cisplatin by vein.
- You will receive interferon alfa-2b by injection into fatty tissue.
- Blood (up to 4 teaspoons) will be drawn for routine tests.
On Day 5 of each cycle:
- You will receive nab-paclitaxel by vein over about 30 minutes.
- You will receive interferon alfa-2b by injection into fatty tissue.
- Blood (up to 4 teaspoons) will be drawn for routine tests.
Depending on how your body reacts to the study drugs, you will stay in the hospital for 7 or more days.
After you are discharged from the hospital, blood (up to 4 teaspoons) will be drawn 2 times a week for routine tests.
Study Visits:
Before starting each cycle of treatment:
- Your medical history will be recorded.
- You will have a physical exam.
- Blood (about 1-2 tablespoons) will be drawn for routine tests and to check your blood counts.
- You will have a chest x-ray.
After every 2 cycles of treatment, you will have CT scans and an MRI scan of the brain to check the status of the disease. If you have disease in the bone, you will have a PET/CT to check the status of the disease.
If you have skin lesions, you will have them photographed to check the status of the disease.
Length of Study:
You may receive up to 6 cycles of the study drugs. You will be taken off study early if the disease gets worse or intolerable side effects occur.
Follow-Up Contact:
If you are having follow-up visits with a doctor who is not at M. D. Anderson, you will be called 2-4 times a year to learn what treatments you may be receiving and how are you doing. You will continue to receive these calls for as long as possible. The phone calls will take about 5 minutes.
This is an investigational study. Nab-paclitaxel is FDA approved and commercially available for breast cancer. Temozolomide is FDA approved and commercially available for brain cancer. Cisplatin is FDA approved and commercially available for testicular, ovarian, and bladder cancers. Interferon is FDA approved and commercially available for patients with melanoma who are having surgery. IL-2 is FDA approved and commercially available for melanoma and kidney cancer. The combination of these drugs is investigational.
Up to 24 patients will be take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Melanoma
- Being tested
- Temozolomide, Abraxane, Cisplatin, Interleukin-2, Interferon alpha 2b
- Keywords
- Melanoma, Abraxane, Nab-paclitaxel, Paclitaxel (protein-bound), ABI-007, Cisplatin, Platinol-AQ, Platinol, CDDP, Interleukin 2, IL-2, Proleukin, Intron A, Interferon alpha 2b, Interferon alfa-2b, Temodar, Temozolomide
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar
250 mg/m^2 by mouth on days 1, 2, and 3 of each 21-day cycle.
AbraxaneDrug
Also called Nab-paclitaxel, Paclitaxel (protein-bound), ABI-007
100 mg/m^2 given in a short intravenous infusion 1 hour after completion of Temozolomide and a 2nd dose of 70 mg/m^2 given on day 5 of each 21-day cycle.
CisplatinDrug
Also called Platinol-AQ, Platinol, CDDP
20 mg/m^2 intravenously on days 1, 2, 3, and 4 delivered immediately after Abraxane of each 21-day cycle.
Interleukin-2Biological
Also called IL-2, Proleukin
9 MIU/m^2 in a continuous intravenous infusion over 24 hours on days 1, 2, 3, and 4 (total of 96 hours) beginning after completion of Cisplatin of each 21-day cycle.
Interferon alpha 2bBiological
Also called Intron A
5 MIU/m^2 in subcutaneous injection on days 1, 2, 3, 4, and 5 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Biochemotherapy | Experimental | Abraxane with Cisplatin, Temozolomide, interleukin-2 and interferon a2b Receives: Drug: Temozolomide; Drug: Abraxane; Drug: Cisplatin; Biological: Interleukin-2; Biological: Interferon alpha 2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: Radiographic studies (CT, MRI scans) to assess disease response after every two cycles (one cycle=21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas E. Papadopoulos, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970996
- Sponsor's protocol ID
- 2009-0124
- Acronym
- BCAA
- Status last verified
- Dec 2012
- First submitted
- 2 Sep 2009
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Biochemotherapy With Cisplatin, Temozolomide, With Increasing Doses of Abraxane, Combined With Interleukin-2 and Interferon in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00970996
- Acronym / sponsor ID
- BCAA / 2009-0124
- Conditions
- Melanoma
- Keywords
- Melanoma, Abraxane, Nab-paclitaxel, Paclitaxel (protein-bound), ABI-007, Cisplatin, Platinol-AQ, Platinol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Sep 2009 (estimated)
- Results
- Not posted in the source record
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 find the highest tolerable dose of Abraxane (nab-paclitaxel) when given in combination with cisplatin, Temodar (temozolomide), interferon alfa-2b, and interleukin-2 (IL-2) to patients with metastatic melanoma.
Primary Objective:
- The primary objective of the Phase I is to determine the toxicity, safety and the maximum tolerated dose maximum tolerated dose of Abraxane in combination with Cisplatin, Temozolomide, interleukin-2 and interferon a2b in patients with metastatic melanoma.
Secondary Objectives:
- To assess responses to the combination.
- To evaluate the duration of response and the overall survival.
- To determine the effectiveness in delaying the appearance of Central Nervous System disease.
Detailed description
The Study Drugs:
Cisplatin, nab-paclitaxel, and temozolomide are chemotherapy drugs and have a direct effect on melanoma cells. Interferon alfa-2b and IL-2 are biotherapy drugs that stimulate the immune system to fight against melanoma. The combination of chemotherapy and biotherapy drugs is called biochemotherapy.
This is the first study using these drugs in combination.
Catheter:
If you are found to be eligible to take part in this study, you will have a central venous catheter (CVC) inserted, if you do not already have one. The catheter is passed through the veins of your arm or the veins that run under your collar bone to reach a wide central vein in the chest that runs above your heart. You will receive a separate consent form for this procedure, which describes the risks.
Nab-paclitaxel, cisplatin, and interleukin-2 are given through this catheter. In certain situations, blood can also be drawn from this catheter.
Study Drug Dose Levels:
You will be assigned to a dose level of nab-paclitaxel based on when you joined this study. Up to 3 dose levels of nab-paclitaxel will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of nab-paclitaxel that can be given in combination with the other drugs is found.
All participants will receive the same dose level of temozolomide, cisplatin, interferon alfa-2b, and IL-2.
Study Drug Administration:
Each study cycle will last 3-5 weeks. The length of each cycle will depend on your recovery from the study drugs.
On Day 1 of each cycle:
- You will take temozolomide by mouth.
- You will receive nab-paclitaxel over about 30 minutes by vein about 1 hour after you take temozolomide.
- You will then receive cisplatin by vein. Each infusion of cisplatin will take about 45-120 minutes.
- You will receive interferon alfa-2b by injection into fatty tissue.
- You will begin your IL-2 infusion. The infusion will begin after you receive cisplatin and will continue non-stop until Day 5.
On Day 2 of each cycle:
- You will take temozolomide by mouth.
- You will receive cisplatin by vein about 1 hour after you take temozolomide.
- You will receive interferon alfa-2b by injection into fatty tissue.
On Day 3 of each cycle:
- You will take temozolomide by mouth.
- You will receive cisplatin by vein about 1 hour after you take temozolomide.
- You will receive interferon alfa-2b by injection into fatty tissue.
- Blood (up to 4 teaspoons total) will be drawn for routine tests and tests to check for infection in the blood.
On Day 4 of each cycle:
- You will receive cisplatin by vein.
- You will receive interferon alfa-2b by injection into fatty tissue.
- Blood (up to 4 teaspoons) will be drawn for routine tests.
On Day 5 of each cycle:
- You will receive nab-paclitaxel by vein over about 30 minutes.
- You will receive interferon alfa-2b by injection into fatty tissue.
- Blood (up to 4 teaspoons) will be drawn for routine tests.
Depending on how your body reacts to the study drugs, you will stay in the hospital for 7 or more days.
After you are discharged from the hospital, blood (up to 4 teaspoons) will be drawn 2 times a week for routine tests.
Study Visits:
Before starting each cycle of treatment:
- Your medical history will be recorded.
- You will have a physical exam.
- Blood (about 1-2 tablespoons) will be drawn for routine tests and to check your blood counts.
- You will have a chest x-ray.
After every 2 cycles of treatment, you will have CT scans and an MRI scan of the brain to check the status of the disease. If you have disease in the bone, you will have a PET/CT to check the status of the disease.
If you have skin lesions, you will have them photographed to check the status of the disease.
Length of Study:
You may receive up to 6 cycles of the study drugs. You will be taken off study early if the disease gets worse or intolerable side effects occur.
Follow-Up Contact:
If you are having follow-up visits with a doctor who is not at M. D. Anderson, you will be called 2-4 times a year to learn what treatments you may be receiving and how are you doing. You will continue to receive these calls for as long as possible. The phone calls will take about 5 minutes.
This is an investigational study. Nab-paclitaxel is FDA approved and commercially available for breast cancer. Temozolomide is FDA approved and commercially available for brain cancer. Cisplatin is FDA approved and commercially available for testicular, ovarian, and bladder cancers. Interferon is FDA approved and commercially available for patients with melanoma who are having surgery. IL-2 is FDA approved and commercially available for melanoma and kidney cancer. The combination of these drugs is investigational.
Up to 24 patients will be take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biochemotherapy | Experimental | Drug: Temozolomide, Drug: Abraxane, Drug: Cisplatin, Biological: Interleukin-2, Biological: Interferon alpha 2bAbraxane with Cisplatin, Temozolomide, interleukin-2 and interferon a2b |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III melanoma are eligible.
- They should have recurrent melanoma with measurable or evaluable sites of disease, 1.0 cm or larger, in order to assess the response to treatment by RECIST.
- They should not have been exposed to any previous chemotherapy or isolation perfusion for malignant melanoma and have had no previous exposure to interleukin-2. Prior adjuvant interferon is permitted.Prior radiation therapy for metastatic melanoma is permitted provided the patient has un-irradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
- Patients between 18 years of age and 65 years of age with an expected survival greater than 8 weeks and a Karnofsky performance status of 50% or better or an ECOG performance status of 0, 1 or 2 will be eligible.
- They should have normal blood counts with a WBC count of more than or equal to 3000/mm^3 an absolute neutrophil count of more than or equal to 1500/mm^3 and a platelet count of more than 100,000/mm^3 and have no impairment of renal function (serum creatinine less than 1.1 mg/dl for females and less than 1.4 mg/dl for males), hepatic function (serum bilirubin level of less than 1.2 mg/dl) and no evidence of significant cardiac or pulmonary dysfunction.
Key exclusion criteria (8 listed)
- Patients with bone metastases only.
- Patients with brain metastases unless their disease has been resected and they are off corticosteroids. Patients with spinal cord compression and leptomeningeal disease. No major surgery or radiation therapy within 21 days before starting treatment.
- Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (EF less than 55%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy. Patients with an EKG disclosing an absolute QT interval greater than 460 msec in the presence of serum potassium greater than or equal 4.0 mEq/L and magnesium greater than/=1.8 mg/dL.
- Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of FEV1 to less than 75% of predicted normal values.
- Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma.
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 |
|---|---|---|
| TemozolomideAlso: Temodar250 mg/m^2 by mouth on days 1, 2, and 3 of each 21-day cycle. | Drug | Biochemotherapy |
| AbraxaneAlso: Nab-paclitaxel, Paclitaxel (protein-bound), ABI-007100 mg/m^2 given in a short intravenous infusion 1 hour after completion of Temozolomide and a 2nd dose of 70 mg/m^2 given on day 5 of each 21-day cycle. | Drug | Biochemotherapy |
| CisplatinAlso: Platinol-AQ, Platinol, CDDP20 mg/m^2 intravenously on days 1, 2, 3, and 4 delivered immediately after Abraxane of each 21-day cycle. | Drug | Biochemotherapy |
| Interleukin-2Also: IL-2, Proleukin9 MIU/m^2 in a continuous intravenous infusion over 24 hours on days 1, 2, 3, and 4 (total of 96 hours) beginning after completion of Cisplatin of each 21-day cycle. | Biological | Biochemotherapy |
| Interferon alpha 2bAlso: Intron A5 MIU/m^2 in subcutaneous injection on days 1, 2, 3, 4, and 5 of each 21-day cycle. | Biological | Biochemotherapy |
Primary outcome
Response Rate
Time frame: Radiographic studies (CT, MRI scans) to assess disease response after every two cycles (one cycle=21 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- U.T. M.D. Anderson Cancer Center web pageLink 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.
Nicholas E. Papadopoulos, 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 1 study testing Temozolomide, Abraxane and Cisplatin in people with Melanoma, 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 3 Jan 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response Rate (time frame: Radiographic studies (CT, MRI scans) to assess disease response after every two cycles (one cycle=21 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2013.