Brain and Central Nervous System TumorsPhase 2NCT00002931
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer
A Phase 2 study testing filgrastim, carboplatin and etoposide in people with Brain and Central Nervous System Tumors and Extragonadal Germ Cell Tumor, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 16 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer
- What is being tested?
- filgrastim, carboplatin 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
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1997to Dec 2014
- Phase
- Phase 2
- 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 16 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Evaluable germ cell cancer (measurable by radiographic study and/or serum tumor marker elevation) and not curable by standard salvage therapy OR viable cancer on resection of post-chemotherapy residual masses in either intermediate or high risk category
- Bidimensionally measurable disease with measurements performed within 21 days of study entry
- Tumor marker (alpha-fetoprotein, lactate dehydrogenase, beta-human chorionic gonadotropin) studies performed within 7 days prior to study entry
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 120,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.6 mg/dL
- SGOT and SGPT no greater than 2 times upper limit of normal (ULN)
- No active hepatitis or cirrhosis
Renal:
- Creatinine clearance at least 70 mL/min
Cardiovascular:
- Ejection fraction (MUGA or echocardiogram) normal
- No EKG evidence of active cardiac disease (arrhythmias, ischemia) which would contraindicate etoposide and paclitaxel study treatment
Pulmonary:
- PaO_2 at least 70 mm Hg
- FEV_1 at least 2 L or 75%
- No history of bleomycin associated or serious lung disease
Neurologic:
- No steroid or glucocorticoid treatment for patients with CNS metastatic disease; at least 1 month with stable post-radiotherapy neurological status and seizure free; if prior seizures, at least 1 month with therapeutic anticonvulsant levels prior to study
- Prior peripheral neuropathy requires consultation with principal investigator
Other:
- No significant active medical illness precluding study or survival
- Not HIV positive
- No prior malignancy within past 5 years except for adequately treated basal cell or squamous cell skin cancer
- No prior hematologic malignancies
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior bone marrow or stem cell rescue with high-dose chemotherapy
Chemotherapy:
- Prior chemotherapy allowed, excluding high-dose therapy with bone marrow or stem cell rescue
- No prior paclitaxel
Endocrine therapy:
- Not specified
Radiotherapy:
- No concurrent radiotherapy during study
Surgery:
- Recovered from prior surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer.
Read the detailed description
OBJECTIVES:
- Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens with autologous stem cell rescue in patients with relapsed germ cell cancer.
- Evaluate the toxic effects of paclitaxel, carboplatin and etoposide (VP-16) with stem cell support followed by paclitaxel, carboplatin and ifosfamide with stem cell support in these patients.
OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells cannot be collected.
Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours, then CBDCA and ifosfamide on days -6 to -4.
Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV is given twice a day until 3 consecutive postnadir days of granulocytes of at least 1000/mm^3 are maintained. On day 0, stem cells with or without bone marrow product are again administered.
Surgery may be performed after course 2 if indicated.
PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year over 2 years.
- Conditions
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor
- Being tested
- filgrastim, carboplatin, etoposide, ifosfamide, paclitaxel
- Keywords
- recurrent malignant testicular germ cell tumor, testicular seminoma, testicular embryonal carcinoma, testicular choriocarcinoma, testicular yolk sac tumor, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and seminoma, testicular yolk sac tumor and teratoma, testicular yolk sac tumor and teratoma with seminoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and seminoma, recurrent ovarian germ cell tumor, recurrent extragonadal non-seminomatous germ cell tumor, recurrent extragonadal seminoma, recurrent extragonadal germ cell tumor
- Medical subject headings
- Central Nervous System Neoplasms, Ovarian Neoplasms, Teratoma, Testicular Germ Cell Tumor, Testicular Neoplasms, Seminoma, Endodermal Sinus Tumor, Carcinoma, Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.
carboplatinDrug
AUC=7, daily X 3
etoposideDrug
20 mg/kg by 2 hours infusion daily X 3
ifosfamideDrug
3 gm/m2 IV over 30 minutes X 3 days
paclitaxelDrug
425 mg/m2 as 24 hour continuous infusion
autologous bone marrow transplantationProcedure or surgery
Given in two divided infusions on day -2 and day 0
bone marrow ablation with stem cell supportProcedure or surgery
Two cycles of high dose chemotherapy followed by stem cell reinfusion
| Study group | Role | What they receive |
|---|---|---|
| HD Chemo and Auto Stem Cells | Experimental | Not described Receives: Biological: filgrastim; Drug: carboplatin; Drug: etoposide; Drug: ifosfamide; Drug: paclitaxel; Procedure: autologous bone marrow transplantation; Procedure: bone marrow ablation with stem cell support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.
Measured: Until disease progression, up to 5 years.
Toxic Effects
Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy
Measured: From date of randomization until death of any cause, assessed up to 12 weeks
Secondary outcomes (1)
Overall Survival
Estimated using the product-limit method of Kaplan and Meier.
Measured: Until death from any cause, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startFeb 1997
- Primary completionDec 2014
- Study completionDec 2014
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.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by City of Hope Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sumanta Pal, MD, Study chair, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002931
- Sponsor's protocol ID
- 96126
- Other IDs
- P30CA033572, CHNMC-96126, NCI-G97-1136, CDR0000065365
- Status last verified
- Jan 2017
- First submitted
- 1 Nov 1999
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer
- ClinicalTrials.gov ID
- NCT00002931
- Acronym / sponsor ID
- 96126
- Conditions
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor
- Keywords
- recurrent malignant testicular germ cell tumor, testicular seminoma, testicular embryonal carcinoma, testicular choriocarcinoma, testicular yolk sac tumor, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and yolk sac tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1997
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 4 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer.
Detailed description
OBJECTIVES:
- Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens with autologous stem cell rescue in patients with relapsed germ cell cancer.
- Evaluate the toxic effects of paclitaxel, carboplatin and etoposide (VP-16) with stem cell support followed by paclitaxel, carboplatin and ifosfamide with stem cell support in these patients.
OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells cannot be collected.
Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours, then CBDCA and ifosfamide on days -6 to -4.
Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV is given twice a day until 3 consecutive postnadir days of granulocytes of at least 1000/mm^3 are maintained. On day 0, stem cells with or without bone marrow product are again administered.
Surgery may be performed after course 2 if indicated.
PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year over 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HD Chemo and Auto Stem Cells | Experimental | Biological: filgrastim, Drug: carboplatin, Drug: etoposide, Drug: ifosfamide, Drug: paclitaxel, Procedure: autologous bone marrow transplantation, Procedure: bone marrow ablation with stem cell support |
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| filgrastim5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection. | Biological | HD Chemo and Auto Stem Cells |
| carboplatinAUC=7, daily X 3 | Drug | HD Chemo and Auto Stem Cells |
| etoposide20 mg/kg by 2 hours infusion daily X 3 | Drug | HD Chemo and Auto Stem Cells |
| ifosfamide3 gm/m2 IV over 30 minutes X 3 days | Drug | HD Chemo and Auto Stem Cells |
| paclitaxel425 mg/m2 as 24 hour continuous infusion | Drug | HD Chemo and Auto Stem Cells |
| autologous bone marrow transplantationGiven in two divided infusions on day -2 and day 0 | Procedure or surgery | HD Chemo and Auto Stem Cells |
| bone marrow ablation with stem cell supportTwo cycles of high dose chemotherapy followed by stem cell reinfusion | Procedure or surgery | HD Chemo and Auto Stem Cells |
Primary outcome
Progression-free Survival
Time frame: Until disease progression, up to 5 years.
Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.
Toxic Effects
Time frame: From date of randomization until death of any cause, assessed up to 12 weeks
Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy
1 secondary outcome
Overall Survival
Time frame: Until death from any cause, up to 5 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sumanta Pal, MD study chair
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, carboplatin and etoposide in people with Brain and Central Nervous System Tumors and Extragonadal Germ Cell Tumor, run by City of Hope Medical 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?
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 23 Feb 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Jan 2017). 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?
Progression-free Survival (time frame: Until disease progression, up to 5 years.). 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?
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 23 Feb 2017.