NCT00010127

Brief Summary

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill prostate tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_1 prostate-cancer

Timeline
Completed

Started Nov 2000

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 30, 2003

Completed
Last Updated

March 21, 2013

Status Verified

December 1, 2008

First QC Date

February 2, 2001

Last Update Submit

March 19, 2013

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IV prostate cancer

Interventions

therapeutic autologous dendritic cellsBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the prostate * Stage D1-3 * Regional lymph node, bone, visceral, or soft tissue metastases * No transitional cell or small cell carcinoma * Testosterone less than 50 mg/L if prior treatment with luteinizing hormone releasing hormone (LHRH) analogues or estrogens * Evidence of androgen refractory disease after surgical castration and discontinuation of LHRH analogue therapy * No previously irradiated or new CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * More than 6 months Hematopoietic: * WBC at least 3,000/mm\^3 * Hemoglobin at least 9 g/dL * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * PT at least 11.3 seconds but no greater than 13.3 seconds * PTT at least 20.1 seconds but no greater than 32.9 seconds * No hepatic disease * No viral hepatitis Renal: * Creatinine less than 2.5 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease Pulmonary: * No asthma * No chronic obstructive pulmonary disease * No severe lung disease Other: * No other medical illness or psychological impediment that would preclude study * No other concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer * No active acute or chronic infection including symptomatic urinary tract infection * No autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis) * HIV negative * Adequate peripheral vein access PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior biologic therapy allowed * No other concurrent immunotherapy Chemotherapy: * Prior chemotherapy allowed * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior non-steroidal hormonal therapy if increase in PSA while receiving non-steroidal hormonal therapy * At least 6 weeks since prior steroids * Concurrent LHRH analogues for gonadal androgen suppression allowed * No concurrent steroid therapy * No concurrent corticosteroids Radiotherapy: * See Disease Characteristics * Prior palliative radiotherapy for bone metastases allowed * Prior prostatic radiotherapy allowed * At least 4 weeks since prior radiotherapy * At least 12 weeks since prior strontium chloride Sr 89 * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * Recovered from prior therapy * No concurrent immunosuppressive agents (e.g., azathioprine or cyclosporine)

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

Sponsors & Collaborators

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Johannes Vieweg, MD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2001

First Posted

July 30, 2003

Study Start

November 1, 2000

Study Completion

March 1, 2003

Last Updated

March 21, 2013

Record last verified: 2008-12

Locations

US(1)