Clinical trial NCT00002931
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 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 adult teratoma testicular immature teratoma testicular mature teratoma ovarian immature teratoma ovarian mature teratoma ovarian monodermal and highly specialized teratoma stage III malignant testicular germ cell tumor stage IV ovarian germ cell tumor stage IV extragonadal non-seminomatous germ cell tumor stage IV extragonadal seminoma adult central nervous system germ cell tumor
Sponsor: City of Hope Medical Center
Start date: 1997-02-01; Completion date: 2014-12-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: None
Interventions: intervention 1: filgrastim intervention 2: carboplatin intervention 3: etoposide intervention 4: ifosfamide intervention 5: paclitaxel intervention 6: autologous bone marrow transplantation intervention 7: bone marrow ablation with stem cell support
Intervention descriptions: intervention 1: 5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection. intervention 2: AUC=7, daily X 3 intervention 3: 20 mg/kg by 2 hours infusion daily X 3 intervention 4: 3 gm/m2 IV over 30 minutes X 3 days intervention 5: 425 mg/m2 as 24 hour continuous infusion intervention 6: Given in two divided infusions on day -2 and day 0 intervention 7: Two cycles of high dose chemotherapy followed by stem cell reinfusion

Protocol documents: