Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSA prostate cancer vaccine | Biological | — | UNRESOLVED |
| recombinant interleukin-12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PSMA peptide vaccine
- description
- 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.
- interventionNames
- Biological: PSA prostate cancer vaccine
- Biological: recombinant interleukin-12
Primary outcomes (1)
- measure
- Disease response
- timeFrame
- 63 days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available