Overview
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Prostate Cancer
Status:
Completed
Completed
Trial end date:
2000-03-01
2000-03-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation followed by combination chemotherapy in treating patients with metastatic prostate cancer that has not responded to hormone therapy.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of Maryland Greenebaum Cancer CenterUniversity of Maryland, Baltimore
Treatments:
CarmustineMelphalan
Vinorelbine
Criteria
DISEASE CHARACTERISTICS: Histologically proven metastatic hormone refractory adenocarcinomaof the prostate that is progressive on hormone based therapy, as demonstrated by: New
metastatic lesion Consecutive series of increasing PSA levels following hormonal therapy No
CNS disease
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 (unless due to bone
pain) Life expectancy: Not specified Hematopoietic: CD34+ at least 4 million/kg Hepatic:
Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of
normal No active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 3
mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: FVC, FEV1,
and corrected DLCO at least 50% of predicted (high resolution CT scan of chest and P02 at
least 70 if unable to complete PFTs) Other: No active infection requiring intravenous
antibiotics Not HIV positive
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than one
course of cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics
Radiotherapy: Not specified Surgery: Not specified