Cancer, Prostate |
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Clinical Trial: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Prostate Cancer
This study is no longer recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage IV prostate cancer adenocarcinoma of the prostate recurrent prostate cancer Quality of Life | Drug: carmustine Drug: cisplatin Drug: filgrastim Drug: melphalan Drug: vinorelbine | Phase II |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of High Dose Chemotherapy with Peripheral Stem Cell Transplantation Followed by Consolidation Chemotherapy in Patients with Metastatic Hormone Refractory Prostate Cancer
Study start: September 1998
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.
PROTOCOL 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.
Eligibility
Ages Eligible for Study: 18 Years - 70 Years
Criteria
PROTOCOL ENTRY 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
--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
--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
Location Information
Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, 21201, United States
Guido J. Tricot, Study Chair, University of Maryland Greenebaum Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: August 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003400
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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