Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

University of Virginia

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin); Intraocular Melanoma

Treatments: Biological: multi-epitope melanoma peptide vaccine; Biological: sargramostim; Biological: incomplete Freund's adjuvant

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00089206

UVACC-MEL-42

UVACC-24802

10049

Details and patient eligibility

About

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

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

Full description

OBJECTIVES:

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

OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response.

PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.

Enrollment: 7 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of melanoma

  • Unresectable stage III or IV disease
  • Mucosal or ocular disease allowed

• Positive HLA-A1, -A2, or -A3 expression

PATIENT CHARACTERISTICS:

Age

• 12 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

• Weight ≥ 100 pounds
• Not pregnant or nursing
• No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior vaccination with any of the peptides used in this protocol
• More than 1 year since prior melanoma vaccine therapy
• More than 4 weeks since prior immunotherapy
• More than 4 weeks since prior growth factors
• More than 4 weeks since prior allergy shots

Chemotherapy

• More than 4 weeks since prior chemotherapy

Endocrine therapy

• More than 4 weeks since prior steroid therapy

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Prior tumor resection allowed

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)