Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: PSA prostate cancer vaccine Biological: recombinant interleukin-12 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prostate Cancer |
- Disease response [ Time Frame: 63 days ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | November 2001 |
| Study Completion Date: | January 2005 |
| Primary Completion Date: | March 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Biological: PSA prostate cancer vaccine
Biological: recombinant interleukin-12
Other Name: IL-12, rhIL-12
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Study Chair: | Thomas F. Gajewski, MD, PhD | University of Chicago |
More Information
Additional Information:
No publications provided
| Responsible Party: | Thomas Gajewski, Associate Professor, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00015977 History of Changes |
| Other Study ID Numbers: | 9845, UCCRC-9845, NCI-1192 |
| Study First Received: | May 6, 2001 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Chicago:
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Interleukin-12 Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses Adjuvants, Immunologic Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013