Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer
filgrastim
+ carboplatin
+ etoposide
Urogenital Diseases+28
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: February 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 16 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
City of Hope Comprehensive Cancer Center
Duarte, United StatesOpen City of Hope Comprehensive Cancer Center in Google Maps