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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Etoposide; Ifosfamide; Paclitaxel

Criteria

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