NCT00009750

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy and chemotherapy with peripheral stem cell transplantation may be an effective treatment for metastatic prostate cancer. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy plus chemotherapy followed by peripheral stem cell transplantation in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 2, 2001

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 20, 2013

Status Verified

November 1, 2003

First QC Date

February 2, 2001

Last Update Submit

September 19, 2013

Conditions

Prostate Cancer

Keywords

stage IV prostate cancerrecurrent prostate cancer

Interventions

filgrastimBIOLOGICAL
monoclonal antibody m170BIOLOGICAL
cyclosporineDRUG
paclitaxelDRUG
peripheral blood stem cell transplantationPROCEDURE
indium In 111 monoclonal antibody m170RADIATION
yttrium Y 90 monoclonal antibody m170RADIATION

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hormone-refractory metastatic prostate cancer * Hormonal ablation (surgical or chemical) at least 3 months prior to study * HAMA titer negative * Less than 25% bone marrow involvement by metastatic prostate cancer PATIENT CHARACTERISTICS: Age: * 18 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 100,00/mm\^3 * Hemoglobin at least 10.0 g/dL (without transfusion) * No chronic transfusion requirement Hepatic: * Bilirubin no greater than 1.3 mg/dL * AST no greater than 1.5 times normal Renal: * Creatinine less than 1.5 mg/dL Cardiovascular: * LVEF at least 50% by MUGA * No disseminated intravascular coagulation Pulmonary: * FEV1 at least 65% of predicted * FVC at least 65% of predicted * Corrected DLCO at least 60% Other: * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior murine protein (e.g., ProstaScint) Chemotherapy: * At least 4 weeks since prior standard dose chemotherapy Endocrine therapy: * See Disease Characteristics Radiotherapy: * At least 4 weeks since prior external beam radiotherapy * No prior radiotherapy to no more than 25% of total skeleton Surgery: * See Disease Characteristics Other: * No concurrent oral anticoagulants (low dose coumadin for central line thrombosis prophylaxis allowed) * No concurrent chronic transfusions

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

Sponsors & Collaborators

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

FilgrastimM1-70 monoclonal antibodyCyclosporinePaclitaxelPeripheral Blood Stem Cell TransplantationIndium

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 FactorsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeMetals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • Carol M. Richman, MD

    University of California, Davis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2001

First Posted

January 27, 2003

Study Start

March 1, 2001

Last Updated

September 20, 2013

Record last verified: 2003-11

Locations

US(1)