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

NCT ID: NCT00089206

Last Updated: 2014-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31

Brief Summary

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.

Detailed 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.

Conditions

Intraocular Melanoma; Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma; recurrent intraocular melanoma; iris melanoma; extraocular extension melanoma; ciliary body and choroid melanoma, medium/large size

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

incomplete Freund's adjuvant

Intervention Type: BIOLOGICAL

multi-epitope melanoma peptide vaccine

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Craig L Slingluff, Jr

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig L. Slingluff, MD

Role: STUDY_CHAIR

University of Virginia

Locations

Cancer Center at the University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

UVACC-MEL-42

Identifier Type: -

Identifier Source: secondary_id

UVACC-24802

Identifier Type: -

Identifier Source: secondary_id

10049

Identifier Type: -

Identifier Source: org_study_id