Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: aldesleukin; gp100 antigen; incomplete Freund's adjuvant; sargramostim; tetanus peptide melanoma vaccine; tyrosinase peptide
Intervention description: Systemic subcutaneous delivery of low-dose IL-2.
Intervention MeSH terms: Aldesleukin; Interleukin-2; Sargramostim; Freund's Adjuvant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: stage III melanoma; stage IV melanoma; recurrent melanoma

Summary:

      RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to
      and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of
      immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a
      person's white blood cells to kill melanoma cells. Combining vaccine therapy with GM-CSF and
      interleukin-2 may be kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of vaccines made from melanoma cells with
      or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV
      melanoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage III or IV melanoma
        gp100 positive tumor cells and/or tyrosinase positive tumor cells HLA type A1, A2, or A3
        Measurable disease May have up to 3 brain metastases if all are less than 2 cm in diameter
        and are asymptomatic, and there is no mass effect or they have been treated successfully by
        surgical excision or by gamma knife radiation therapy

        PATIENT CHARACTERISTICS: Age: 18 to 79 Performance status: ECOG 0-1 Life expectancy: Not
        specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count
        greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin no greater than
        2.5 times upper limit of normal (ULN) AST and ALT no greater than 2.5 times ULN Alkaline
        phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN
        Cardiovascular: No New York Heart Association class II, III, or IV heart disease Other: No
        known or suspected allergy to any component of the vaccine No medical condition that would
        preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use
        effective contraception

        PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior growth factors At
        least 3 months since prior agents with putative immunomodulating activity (except
        nonsteroidal antiinflammatory agents) At least 1 year since other prior melanoma
        vaccinations Chemotherapy: At least 3 months since prior chemotherapy No concurrent
        chemotherapy Endocrine therapy: At least 3 months since prior corticosteroids No concurrent
        corticosteroids Radiotherapy: At least 3 months since prior radiotherapy No concurrent
        radiotherapy Surgery: See Disease Characteristics Other: At least 3 months since other
        prior investigational drugs or therapy At least 3 months since prior allergy
        desensitization injections At least 14 days since completion of acute treatment for a
        serious infection No concurrent allergy desensitization injections