NCT00039299

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's T cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of T-cell therapy in treating patients who have 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

Timeline
Completed

Started Mar 2002

Shorter than P25 for phase_1 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2002

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

April 4, 2013

Status Verified

June 1, 2003

First QC Date

June 6, 2002

Last Update Submit

April 2, 2013

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostaterecurrent prostate cancer

Interventions

therapeutic autologous lymphocytesBIOLOGICAL

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Evidence of androgen-independent disease * Patient must have received prior primary hormonal therapy (e.g., orchiectomy or gonadotropin-releasing hormone analog with or without antiandrogen) * Demonstrated disease progression by any 1 of the following: * Elevated PSA level (at least 5 ng/mL) that has serially risen from baseline on 2 occasions at least 1 week apart * At least 1 new osseous lesion on bone scan * More than 25% increase in the sum of the products of the perpendicular diameters of all bidimensionally measurable sites of disease * No CNS metastases PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * ECOG 0-1 Life expectancy: * At least 3 months Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGPT no greater than 1.5 times ULN * Hepatitis B surface antigen negative * No active or chronic hepatitis B or C * No other hepatic dysfunction that would preclude study Renal: * Creatinine less than 2.0 mg/dL * Calcium less than 11 mg/dL * No renal dysfunction that would preclude study * No symptomatic hypercalcemia Cardiovascular: * No New York Heart Association class III or IV heart disease Pulmonary: * No pulmonary disease requiring inhaled steroids or bronchodilators Other: * No history of HIV 1 or 2 or human T-cell lymphotrophic virus (HTLV) 1 or 2 * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer * No history of autoimmune disease (e.g., rheumatoid arthritis or multiple sclerosis) * No other major organ system dysfunction * No gastrointestinal, neurologic, or psychiatric dysfunction that would preclude study * Human anti-mouse antibody negative PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent growth factors, interleukin, interferons, or cytokines Chemotherapy: * No prior chemotherapy or other systemic chemotherapy agent for prostate or any other cancer Endocrine therapy: * Prior aminoglutethimide allowed * At least 4 weeks since prior flutamide * At least 6 weeks since prior bicalutamide or nilutamide * Concurrent luteinizing hormone-releasing hormone agonists should be continued * No concurrent corticosteroids or dexamethasone * No concurrent anti-androgens (e.g., flutamide, bicalutamide, or nilutamide) Radiotherapy: * At least 4 weeks since prior local radiotherapy * No prior radiopharmaceutical therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) * No concurrent radiotherapy Surgery: * Not specified Other: * Prior ketoconazole or PC-SPES allowed * At least 1 week since prior antibiotic, antifungal, or antiviral agents * At least 4 weeks since other prior systemic therapy for prostate cancer (except bisphosphonates or hormonal therapy) * At least 6 weeks since prior investigational drugs or devices * No other concurrent therapy for this disease * No concurrent participation in another clinical trial * No concurrent bisphosphonates unless initiated prior to study * No concurrent immunosuppressive drugs * No other concurrent experimental therapies

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

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1738, 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

  • Allan Pantuck, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2002

First Posted

January 27, 2003

Study Start

March 1, 2002

Study Completion

June 1, 2003

Last Updated

April 4, 2013

Record last verified: 2003-06

Locations

US(1)