Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aluminum Hydroxide; Aluminum sulfate; Freund's Adjuvant; Interleukin-12; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of stage IIB, IIC, III, or IV cutaneous melanoma OR stage III or IV ocular or mucosal melanoma

• Resected or rendered disease-free

• HLA-A2.1-positive by standard cytotoxicity assay

• Tumor tissue must be available for analysis of gp100 staining and tyrosinase and MART-1 expression by immunohistochemistry

• Must be positive for at least 1 antigen

• Failed, ineligible for, or refused prior interferon alfa

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9.0 g/dL

• No bleeding disorder

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• SGOT/SGPT no greater than 2.5 times normal

• No coagulation disorder

• Hepatitis surface antigen B negative

• Hepatitis C negative

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No major cardiovascular illness

Pulmonary:

• No major respiratory illness

Immunologic:

• No prior uveitis

• No prior autoimmune inflammatory eye disease

• No immune hemolytic anemia

• No other active autoimmune disease

Other:

• HIV negative

• No major gastrointestinal illness

• No other malignancy within the past 5 years except squamous cell skin cancer or carcinoma in situ of the cervix curatively treated at least 30 days ago

• No major systemic infection (e.g., pneumonia or sepsis)

• No other major medical illness

• No prior allergic reaction to Montanide ISA-51 or alum adjuvant

• No requirement for steroid therapy

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

• No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or MART-1:26-35 (27L) peptides

Chemotherapy:

• At least 1 month since prior adjuvant chemotherapy for this disease

• No concurrent adjuvant chemotherapy

Endocrine therapy:

• No concurrent steroids

Radiotherapy:

• At least 1 month since prior radiotherapy for this disease

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 1 month since other prior therapy, including adjuvant therapy, for this disease

• No other concurrent therapy, including adjuvant therapy