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

NCT ID: NCT00015977

Last Updated: 2014-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2005-01-31

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.

Detailed Description

OBJECTIVES:

• Determine whether immunization with prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells and interleukin-12 can promote specific T-cell priming in patients with metastatic hormone-refractory prostate cancer.
• Determine the clinical response in patients treated with this regimen.

OUTLINE: Patients receive prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells subcutaneously (SC) on day 1 and interleukin-12 SC on days 1, 3, and 5. Treatment repeats every 21 days for 3-9 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 37 weeks.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PSMA peptide vaccine

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.

Group Type: EXPERIMENTAL

PSA prostate cancer vaccine

Intervention Type: BIOLOGICAL

recombinant interleukin-12

Intervention Type: BIOLOGICAL

Interventions

PSA prostate cancer vaccine

Intervention Type: BIOLOGICAL

recombinant interleukin-12

Intervention Type: BIOLOGICAL

Other Intervention Names

IL-12, rhIL-12

Eligibility Criteria

Inclusion Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas F. Gajewski, MD, PhD

Role: STUDY_CHAIR

University of Chicago

Locations

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

UCCRC-9845

Identifier Type: -

Identifier Source: secondary_id

NCI-1192

Identifier Type: -

Identifier Source: secondary_id

9845

Identifier Type: -

Identifier Source: org_study_id