Vaccine Therapy and Sargramostim in Treating Patients With Stage IV Malignant Melanoma

Completed · Not applicable

Conditions studied: Recurrent Melanoma, Stage IV Melanoma

In brief

This randomized pilot clinical trial studies vaccine therapy and sargramostim in treating patients with stage IV malignant melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment for malignant melanoma

Key facts

Study ID

NCT00006243

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2000-10-01

Last updated by the study team

2013-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Human leukocyte antigen (HLA)-A2 positive
• Histologic proof of stage IV malignant melanoma with measurable disease
• Absolute neutrophil count (ANC) >= 1500
• Platelets (PLT) >= 100,000
• Alkaline phosphatase (Alk phos) =< 3 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) =< 3 x ULN
• Creatinine (Creat) =< 1.5 x ULN
• Hemoglobin (Hgb) > 9.0
• Ability to provide informed consent
• Willingness to return to a Mayo Clinic institution for follow-up
• Life expectancy >= 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

You may not qualify if…

• Uncontrolled or current infection
• Prior immunization with differentiation antigen peptides
• Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy
• Any of the following prior therapies:
• Chemotherapy =< 4 weeks
• Mitomycin C/nitrosoureas =< 6 weeks
• Immunotherapy =<4 weeks
• Biologic therapy =< 4 weeks
• Radiation therapy =< 4 weeks
• Radiation to > 25% of bone marrow
• Failure to fully recover from effects of prior chemotherapy regardless of interval since last treatment
• New York Heart Association classification III or IV
• Seizure disorder
• Any of the following:
• Pregnant women
• Nursing women
• Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
• Other concurrent chemotherapy, immunotherapy, or radiotherapy
• Active psychiatric disorder requiring medications (anti-psychotics)
• Known central nervous system metastases or carcinomatous meningitis
• History of other malignancy in last 5 years with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only (it is impossible to predict the effect of study treatment on other, potentially dormant malignant diseases)
• Known immune deficiency (patients with known immune deficiencies will likely not be able to mount an immune response to the study vaccine)

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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