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

NCT00089206 | Completed Phase 2 DMC

• 3 other identifiers: 10049UVACC-MEL-42UVACC-24802
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

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

Interventions

incomplete Freund's adjuvant BIOLOGICAL

multi-epitope melanoma peptide vaccine BIOLOGICAL

sargramostim BIOLOGICAL

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Virginia: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

incomplete Freund's adjuvant; sargramostim

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Craig L. Slingluff, MD

  University of Virginia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 4, 2004
• First Posted: August 5, 2004
• Study Start: August 1, 2002
• Primary Completion: November 1, 2005
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

US (1)