Clinical trial · Interventional
Vaccine Therapy Plus Sargramostim and Interleukin-2 Compared With Nilutamide Alone in Treating Patients With Prostate Cancer
A Randomized Phase II Study of Either Immunotherapy With a Regimen of Recombinant Pox Viruses That Express PSA/B7.1 Plus Adjuvant GM-CSF and IL2 or Hormone Therapy With Nilutamide in Patients With Hormone Refractory Prostate Cancer and No Radiographic Evidence of Disease
- 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 prostate cancer cells may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill prostate cancer cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using nilutamide may fight prostate cancer by reducing the production of androgens. It is not yet known which treatment regimen is more effective for treating prostate cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus sargramostim and interleukin-2 with that of nilutamide alone in treating patients who have 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| nilutamide | Drug | Nilutamide | ALIAS |
| recombinant fowlpox-prostate specific antigen vaccine | Biological | — | UNRESOLVED |
| recombinant vaccinia-B7.1 vaccine | Biological | — | UNRESOLVED |
| recombinant vaccinia prostate-specific antigen vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed hormone-refractory adenocarcinoma of the prostate * Rising PSA after orchiectomy and/or while receiving at least 1 regimen of luteinizing hormone-releasing hormone (LHRH) * PSA must have risen at least 0.5 ng/mL from baseline on 2 successive measurements during and/or after hormonal therapy * PSA greater than 1.0 ng/mL * If on antiandrogen therapy, must undergo antiandrogen withdrawal for at least 6 weeks and still have evidence of rising PSA * After prior bicalutamide, must undergo withdrawal for at least 6 weeks and still have evidence of rising PSA * Testosterone no greater than 50 ng/mL if no prior orchiectomy * No metastatic disease by bone scan and CT scan or MRI of the abdomen and pelvis and by CT scan or x-ray of the chest * No active or prior CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 OR * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute lymphocyte count at least 600/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8.0 g/dL Hepatic: * Bilirubin no greater than 1.6 mg/dL * AST and ALT no greater than 4 times normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min * Urinalysis normal OR * Proteinuria no greater than 1 g/24-hour urine collection * No hematuria or abnormal sediment unless underlying cause is nonrenal Immunologic: * HIV negative * No altered immune function * No autoimmune disease, including the following: * Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia * Systemic lupus erythematosus, Sjogren's syndrome, or scleroderma * Myasthenia gravis * Goodpasture syndrome * Addison's disease, Hashimoto's thyroiditis, or active Graves' disease * No known allergy or untoward reaction to prior vaccination with vaccinia virus * No known allergy to eggs * No active or prior eczema or other eczematoid skin disorders * No other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, impetigo, varicella zoster, burns, severe acne, or other open rashes or wounds) Other: * No other serious concurrent illness * No active infections within the past 3 days * No history of seizures, encephalitis, or multiple sclerosis * No close or household contact for at least 2 weeks after each vaccinia virus inoculation with the following high-risk individuals: * Children under 5 years of age * Pregnant or nursing women * Individuals with active or prior eczema or other eczematoid skin disorders, atopic dermatitis, impetigo, varicella zoster, burns, severe acne, or other open rashes or wounds * Immunosuppressed or immunodeficient (by disease or therapy) individuals, including those with HIV infection * No other malignancy within the past 3 years except squamous cell or basal cell skin cancer or other curatively treated malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: * Must have prior vaccinia for smallpox immunization * No other concurrent biologic therapy Chemotherapy: * No prior chemotherapy for prostate cancer * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior hormonal therapy (6 weeks for bicalutamide) and recovered * If disease progression on LHRH antagonist, must continue to receive that LHRH agent or undergo surgical castration * No concurrent steroids unless topical or inhaled * No other concurrent hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * No prior radiotherapy to more than 50% of nodal groups * No concurrent radiotherapy Surgery: * See Disease Characteristics * See Endocrine therapy * At least 4 weeks since prior surgery and recovered * No prior splenectomy Other: * No concurrent homeopathic therapy with PC-SPES or genistein
References
Publications (5)
- BACKGROUNDTsang KY, Zhu M, Even J, Gulley J, Arlen P, Schlom J. The infection of human dendritic cells with recombinant avipox vectors expressing a costimulatory molecule transgene (CD80) to enhance the activation of antigen-specific cytolytic T cells. Cancer Res. 2001 Oct 15;61(20):7568-76. PMID 11606396
- RESULTMadan RA, Gulley JL, Schlom J, Steinberg SM, Liewehr DJ, Dahut WL, Arlen PM. Analysis of overall survival in patients with nonmetastatic castration-resistant prostate cancer treated with vaccine, nilutamide, and combination therapy. Clin Cancer Res. 2008 Jul 15;14(14):4526-31. doi: 10.1158/1078-0432.CCR-07-5048. PMID 18628467
- RESULTArlen PM, Gulley JL, Todd N, Lieberman R, Steinberg SM, Morin S, Bastian A, Marte J, Tsang KY, Beetham P, Grosenbach DW, Schlom J, Dahut W. Antiandrogen, vaccine and combination therapy in patients with nonmetastatic hormone refractory prostate cancer. J Urol. 2005 Aug;174(2):539-46. doi: 10.1097/01.ju.0000165159.33772.5b. PMID 16006888
- RESULTArlen PM, Gulley JL, Novik L, et al.: A randomized phase II trial of either vaccine therapy (recombinant pox viruses expressing PSA and the B7.1 costimulatory molecule) versus hormone therapy (nilutamide) in patients with hormone refractory prostate cancer and no radiographic evidence of disease. [Abstract] J Urol 169 (4 Suppl): A-941, 243, 2003.
- RESULTArlen PM, Gulley J, Novik L, et al.: A randomized phase II trial of either vaccine therapy (recombinant pox viruses expressing PSA and the B7.1 costimulatory molecule) versus hormone therapy (nilutamide) in patients (pts) with hormone refractory prostate cancer and no radiographic evidence of disease. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-728, 2002.