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Analgesics, Non-Narcotic

liposomal interleukin-2

polyvalent melanoma vaccine

recombinant interferon alfa

Jean-Claude Bystryn, MD

RATIONALE: Vaccines may make the body build an immune response and kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Interferon alfa-2b may interfere with the growth of tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus interleukin-2 with or without interferon alfa-2b in treating patients who have stage III melanoma.

OBJECTIVES: I. Determine the effect of interferon alfa-2b on the potentiation of antimelanoma antibodies and cellular immune responses induced by immunization to a polyvalent melanoma vaccine and interleukin-2 in patients with stage III malignant melanoma. II. Determine the optimal dose of interferon that will maximally stimulate these responses in these patients. III. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a randomized study. Patients are randomized into a vaccine treated control arm or to receive one of two doses of interferon alfa-2b plus vaccine. All patients receive polyvalent melanoma vaccine incorporated into interleukin-2 liposomes. The vaccine is administered intradermally every 2 weeks for 8 weeks, monthly for 3 months, and then every 3 months for a total of 2 years or until disease progression. Patients assigned to arms II or III also receive interferon alfa-2b subcutaneously, at one of two doses, three times a week for 2 years. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 18 months.

Vaccine Therapy Plus Interleukin-2 With or Without Interferon Alfa-2b in Treating Patients With Stage III Melanoma

Phase II Trial of the Effects of Interferon Alfa-2b on the Immunogenicity of a Polyvalent Melanoma Antigen Vaccine in Patients With Stage III Malignant Melanoma

National Cancer Institute (NCI)

NYU Langone Health

Immunomodulating Agents

Linda Strause

RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.

OBJECTIVES:

* Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™).

OUTLINE: This is an open-label, multicenter study.

Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™).

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Vaccine Therapy in Treating Patients With Malignant Melanoma

Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™

CancerVax Corporation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vaccine Therapy Plus Interleukin-2 With or Without Interferon Alfa-2b in Treating Patients With Stage III Melanoma	NCT00004104	Melanoma (Skin)	liposomal inter... polyvalent mela... recombinant int...	18 Years - 75 Years	NYU Langone Health
Vaccine Therapy Plus Interleukin-2 With or Without Interferon Alfa-2b in Treating Patients With Stage III Melanoma	NCT00004104	Melanoma (Skin)	liposomal inter... polyvalent mela... recombinant int...	18 Years - 75 Years	NYU Langone Health
Vaccine Therapy in Treating Patients With Malignant Melanoma	NCT00128583	Melanoma (Skin)	polyvalent mela...	18 Years - 80 Years	National Cancer Institute (NCI)
Vaccine Therapy Plus Interleukin-2 With or Without Interferon Alfa-2b in Treating Patients With Stage III Melanoma	NCT00004104	Melanoma (Skin)	liposomal inter... polyvalent mela... recombinant int...	18 Years - 75 Years	NYU Langone Health

Spots Global Cancer Trial Database for polyvalent melanoma vaccine