NCT00002931

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer

Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 16 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain and Central Nervous System Tumors
• Extragonadal Germ Cell Tumor
• Ovarian Cancer
• Teratoma
• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.
DRUG	carboplatin	AUC=7, daily X 3
DRUG	etoposide	20 mg/kg by 2 hours infusion daily X 3
DRUG	ifosfamide	3 gm/m2 IV over 30 minutes X 3 days
DRUG	paclitaxel	425 mg/m2 as 24 hour continuous infusion
PROCEDURE	autologous bone marrow transplantation	Given in two divided infusions on day -2 and day 0
PROCEDURE	bone marrow ablation with stem cell support	Two cycles of high dose chemotherapy followed by stem cell reinfusion

Timeline

• Start date: 1997-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2003-01-27
• Last updated: 2017-02-23
• Results posted: 2017-01-04

Locations

1 site across 1 country: United States