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aldesleukin

fowlpox virus vaccine vector

gp100 antigen

Steven A. Rosenberg, MD, PhD

RATIONALE: Vaccines made from an antigen combined with a modified virus may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells.

PURPOSE: Phase I trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have recurrent metastatic melanoma that has not responded to previous therapy.

OBJECTIVES: I. Evaluate the toxicity, immunologic reactivity, and possible therapeutic efficacy of immunization with recombinant fowlpox virus encoding the gp100 melanoma antigen administered alone or with interleukin-2 in patients with metastatic melanoma.

OUTLINE: This is a dose-escalation study. Patients receive recombinant fowlpox virus encoding the gp100 melanoma antigen (FPV-gp100) IV or intramuscularly to rotating sites or fowlpox virus encoding modified gp100 melanoma antigen IV every 2 weeks for 4 vaccinations. Treatment continues for a maximum of 2 courses in the absence of disease progression. Cohorts of 3-9 patients receive escalating doses of FPV-gp100 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity. Patients in 3 of 5 cohorts also receive interleukin-2 (IL-2) within 12 hours of FPV-gp100. One cohort receives IL-2 subcutaneously daily on days 1-5 and days 8-12. A second cohort receives low-dose IL-2 IV over 15 minutes every 8 hours on days 2-8. A third cohort receives high-dose IL-2 IV over 15 minutes every 8 hours on days 2-6. Patients in cohorts 4 and 5 receive FPV-gp100 alone and, if no response is observed after 2 courses, may receive 2 courses of IL-2 alone every 8 hours for 5 days, approximately 2 weeks apart. A separate cohort of 3-9 patients receives modified FPV-gp100. If no response is observed after 2 courses, IL-2 may be administered as in cohorts 4 and 5. Patients are followed at 28 days after the second immunization with FPV-gp100.

PROJECTED ACCRUAL: A maximum of 91 patients will be accrued for this study.

Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Recurrent Metastatic Melanoma

PHASE I TRIAL IN PATIENTS WITH METASTATIC MELANOMA OF IMMUNIZATION WITH A RECOMBINANT FOWLPOX VIRUS ENCODING THE GP100 MELANOMA ANTIGEN

National Cancer Institute (NCI)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Immunologic Factors

recombinant vaccinia prostate-specific antigen vaccine

Howard L. Kaufman, MD

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of different regimens of PSA vaccines in treating patients who have advanced prostate cancer.

OBJECTIVES: I. Evaluate the effect of prime and boost strategies using recombinant fowlpox prostate specific antigen (PSA) vaccine and recombinant vaccinia PSA vaccine on biochemical PSA progression in patients with stage D0 prostate cancer who have completed local treatment. II. Assess the tolerability and toxicity of these prime and boost treatment regimens in these patients. III. Evaluate the effects of these prime and boost treatment regimens on cellular immunity in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to HLA-2 typing (positive vs negative vs unknown). Patients are randomized to one of three treatment arms. Arm I: Patients receive intramuscular fowlpox prostate specific antigen (PSA) vaccine at weeks 0, 6, 12, and 18. Arm II: Patients receive intramuscular fowlpox PSA vaccine at weeks 0, 6, and 12 and intradermal vaccinia PSA vaccine at week 18. Arm III: Patients receive intradermal vaccinia PSA vaccine at week 0 and intramuscular fowlpox PSA vaccine at weeks 6, 12, and 18. Patients are followed at week 24, then every 3 months until year 2, every 6 months until year 5, and annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study.

PSA Vaccine Therapy in Treating Patients With Advanced Prostate Cancer

Phase II Randomized Study of Vaccine Treatment of Advanced Prostate Cancer

Eastern Cooperative Oncology Group

Group Chair

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Recurrent Metastatic Melanoma	NCT00019175	Melanoma (Skin)	aldesleukin fowlpox virus v... gp100 antigen	18 Years -	National Cancer Institute (NCI)
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Recurrent Metastatic Melanoma	NCT00019175	Melanoma (Skin)	aldesleukin fowlpox virus v... gp100 antigen	18 Years -	National Cancer Institute (NCI)
PSA Vaccine Therapy in Treating Patients With Advanced Prostate Cancer	NCT00003871	Prostate Cancer	fowlpox virus v... recombinant vac...	18 Years - 120 Years	Eastern Cooperative Oncology Group
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Recurrent Metastatic Melanoma	NCT00019175	Melanoma (Skin)	aldesleukin fowlpox virus v... gp100 antigen	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for fowlpox virus vaccine vector