Melanoma Clinical Trial
Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma
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.
Full Description
OBJECTIVES:
Compare the immune reactivity in patients with resected stage IIB, IIC, III, or IV melanoma vaccinated with tyrosinase, gp100, and MART-1 peptides emulsified with Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim (GM-CSF).
OUTLINE: This is a randomized study. Patients are stratified according to disease stage (cutaneous stage IIB, IIC, III, and IV vs ocular and mucosal stage III and IV). Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive vaccine with tyrosinase:368-376 (370D)/gp100:209-217 (210M)/MART-1:26-27 (27L) peptides emulsified with Montanide ISA-51 (ISA-51), low-dose interleukin-12 (IL-12) subcutaneously (SC), and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
Arm II: Patients receive peptide vaccine emulsified with ISA-51, high-dose IL-12 SC, and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
Arm III: Patients receive peptide vaccine emulsified with ISA-51 on day 1 and low-dose IL-12 SC and sargramostim (GM-CSF) SC on days 1-5 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 3 years.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Los Angeles California, 90089, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.