Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

NCT00015977 | Completed Phase 2

• 3 other identifiers: 9845UCCRC-9845NCI-1192
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from a patient's white blood cells may make the body build an immune response to kill cancer cells. Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-12 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy combined with interleukin-12 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Disease response

  63 days

Study Arms (1)

PSMA peptide vaccine

EXPERIMENTAL

Immunization with PSMA peptide vaccine followed by injection of Interleukin-12 (IL-12) on Day 1 of a 21-day cycle. Additional injections of IL-12 given on Days 3 and 5 of each cycle.

Biological: PSA prostate cancer vaccine; Biological: recombinant interleukin-12

Interventions

PSA prostate cancer vaccine BIOLOGICAL

PSMA peptide vaccine

recombinant interleukin-12 BIOLOGICAL

Also known as: IL-12, rhIL-12

PSMA peptide vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the prostate * HLA-A2 positive * Progressive measurable systemic disease * PSA at least 5 ng/mL with 2 consecutive rising PSA levels at least 1 week apart and no measurable disease OR * Objective evidence of disease progression by a 20% increase in the sum of longest diameter of all target lesions or evidence of new lesions by CT or bone scan regardless of PSA status * Lesions must be at least 1 cm to be considered measurable * Progressive systemic disease after discontinuation of anti-androgen therapy * Previously treated with orchiectomy (testosterone less than 50 ng/mL) OR luteinizing hormone-releasing hormone (LHRH) analogue therapy with or without anti-androgens * If on LHRH analogue therapy, must continue therapy during study * Brain metastases allowed if previously treated, clinically stable, and weaned from prior corticosteroids PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 70-100% Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Hemoglobin greater than 9 g/dL * Platelet count greater than 100,000/mm\^3 * No active gastrointestinal bleeding Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGPT normal * Hepatitis B surface antigen negative Renal: * Creatinine less than 1.5 times ULN * Calcium less than 11 mg/dL Cardiovascular: * No significant cardiovascular disease * No cardiac arrhythmia requiring therapy Other: * Fertile patients must use effective barrier contraception * No intrinsic immunosuppression * HIV negative * No serious concurrent infection * No psychiatric illness that would preclude study compliance * No clinically significant autoimmune disease * No uncontrolled peptic ulcer disease * No history of inflammatory bowel disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy Chemotherapy: * Not specified Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior flutamide * At least 6 weeks since prior bicalutamide or nilutamide * No concurrent systemic corticosteroids except physiologic replacement doses Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * No concurrent immunosuppressive drugs (e.g., cyclosporine)

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

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Interleukin-12 Subunit p35; Interleukin-12

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Thomas F. Gajewski, MD, PhD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: November 1, 2001
• Primary Completion: March 1, 2003
• Study Completion: January 1, 2005
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

US (1)