NCT00003400

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Sep 1998

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2000

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

August 16, 2004

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

November 1, 1999

Last Update Submit

October 31, 2019

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IV prostate cancerrecurrent prostate cancer

Interventions

filgrastimBIOLOGICAL
carmustineDRUG
cisplatinDRUG
melphalanDRUG
vinorelbine tartrateDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

FilgrastimCarmustineCisplatinMelphalanVinorelbinePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Guido J. Tricot, MD, PhD

    University of Maryland Greenebaum Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 16, 2004

Study Start

September 1, 1998

Primary Completion

March 1, 2000

Study Completion

March 1, 2000

Last Updated

November 4, 2019

Record last verified: 2019-10

Locations

US(1)