Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer
- Conditions
- Brain and Central Nervous System TumorsExtragonadal Germ Cell TumorOvarian CancerTeratomaTesticular Germ Cell Tumor
- Interventions
- Biological: filgrastimProcedure: autologous bone marrow transplantationProcedure: bone marrow ablation with stem cell support
- Registration Number
- NCT00002931
- Lead Sponsor
- City of Hope Medical Center
- Brief 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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HD Chemo and Auto Stem Cells filgrastim - HD Chemo and Auto Stem Cells autologous bone marrow transplantation - HD Chemo and Auto Stem Cells bone marrow ablation with stem cell support - HD Chemo and Auto Stem Cells carboplatin - HD Chemo and Auto Stem Cells etoposide - HD Chemo and Auto Stem Cells ifosfamide - HD Chemo and Auto Stem Cells paclitaxel -
- Primary Outcome Measures
Name Time Method Progression-free Survival 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 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
- Secondary Outcome Measures
Name Time Method Overall Survival Until death from any cause, up to 5 years. Estimated using the product-limit method of Kaplan and Meier.
Trial Locations
- Locations (1)
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States