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

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.

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