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

Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prostate Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00015977
Enrollment
13
Registered
2003-01-27
Start date
2001-11-30
Completion date
2005-01-31
Last updated
2014-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

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

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.

Interventions

BIOLOGICALrecombinant interleukin-12

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Chicago
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Disease response63 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026