Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer
|ClinicalTrials.gov Identifier: NCT00002931|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 4, 2017
Last Update Posted : February 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor||Biological: filgrastim Drug: carboplatin Drug: etoposide Drug: ifosfamide Drug: paclitaxel Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer|
|Study Start Date :||February 1997|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
|Experimental: HD Chemo and Auto Stem Cells||
5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.Drug: carboplatin
AUC=7, daily X 3Drug: etoposide
20 mg/kg by 2 hours infusion daily X 3Drug: ifosfamide
3 gm/m2 IV over 30 minutes X 3 daysDrug: paclitaxel
425 mg/m2 as 24 hour continuous infusionProcedure: autologous bone marrow transplantation
Given in two divided infusions on day -2 and day 0Procedure: bone marrow ablation with stem cell support
Two cycles of high dose chemotherapy followed by stem cell reinfusion
- 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
- Overall Survival [ Time Frame: Until death from any cause, up to 5 years. ]Estimated using the product-limit method of Kaplan and Meier.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002931
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Study Chair:||Sumanta Pal, MD||City of Hope Medical Center|