Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma

University of Virginia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Melanoma (Skin); Intraocular Melanoma

Treatments: Biological: 6MHP; Biological: GM-CSF; Biological: IFA

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00089219

UVACC-28502

10464

UVACC-MEL-41

Details and patient eligibility

About

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.

Full description

OBJECTIVES:

• Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF).

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.
• Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
• Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.

On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.

PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of stage IIIB, IIIC, or IV melanoma
• HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
• Brain metastases allowed at the discretion of the principle investigator

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3
• Platelet count > 100,000/mm ^3
• Hemoglobin > 9 g/dL

Hepatic

• Liver function tests ≤ 2.5 times upper limit of normal (ULN)

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No New York Heart Association class III or IV heart disease

Other

• Prior diagnosis of other cancer allowed
• Not pregnant or nursing
• Weight ≥ 110 pounds
• No uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 weeks since prior growth factors
• More than 4 weeks since prior allergy shots
• More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine
• No prior vaccination with any of the peptides used in this study

Chemotherapy

• More than 4 weeks since prior chemotherapy

Endocrine therapy

• More than 4 weeks since prior steroids

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• More than 1 month since prior investigational drugs or therapies
• No other concurrent investigational drugs or therapies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Arm A. 6MHP vaccine 200 mcg

Experimental group

Description:

vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)

Treatment:

Biological: IFA

Biological: GM-CSF

Biological: 6MHP

Arm B. 6MHP vaccine 400 mcg

Experimental group

Description:

vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)

Treatment:

Biological: IFA

Biological: GM-CSF

Biological: 6MHP

Arm C. 6MHP vaccine 800 mcg

Experimental group

Description:

vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)

Treatment:

Biological: IFA

Biological: GM-CSF

Biological: 6MHP