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

Melanoma (Skin) Clinical Trial

Official title:

Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00089206
• Other study ID #: 10049
• Secondary ID: UVACC-MEL-42UVAC
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2004
• Last updated: December 18, 2014
• Start date: August 2002

Study information

• Verified date: December 2014
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Melanoma (Skin)
• Uveal Neoplasms

Intervention

Biological:
• incomplete Freund's adjuvant

• multi-epitope melanoma peptide vaccine

• sargramostim

Locations

Country	Name	City	State
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,