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High Dose Chemotherapy With Stem Cell Rescue Followed By Consolidation Treatment in Patients With Metastatic Hormone-Refractory Prostate Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

High Dose Chemotherapy With Stem Cell Rescue Followed By Consolidation Treatment in Patients With Metastatic Hormone-Refractory Prostate Cancer


OBJECTIVES: I. Evaluate the complete and partial remission rates and event free and overall
survival of patients with metastatic hormone refractory prostate cancer treated with high
dose chemotherapy plus peripheral stem cell transplantation followed by consolidation
chemotherapy. II. Evaluate the toxic effects associated with this treatment in these
patients. III. Evaluate the quality of life, and need for analgesics, in these patients.

OUTLINE: Patients are stratified by stage of disease and extent of metastatic disease.
Patients receive daily filgrastim (G-CSF) subcutaneously for 4 days until peripheral blood
stem cells are collected. Patients then receive carmustine IV over 2 hours on day -2 and
melphalan IV over 20 minutes on day -1. Stem cell infusion will be on day 0. At 3, 6, 9, and
12 months after transplant, patients receive vinorelbine IV over 10 minutes and cisplatin IV
over 24 hours. Quality of life and pain are assessed before the transplantation, just before
discharge after transplantation, prior to each consolidation course, and then at 3, 6, and
12 months after the final course of chemotherapy. Patients are followed at least every 3
months for the first 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 18-45 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven metastatic hormone refractory
adenocarcinoma of 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Guido J. Tricot, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066404

NCT ID:

NCT00003400

Start Date:

September 1998

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201