Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery

NCT00003274 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000066176 (10M-97-1)LAC-USC-10M971LAC-USC-FDR001101NCI-T97-0100
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known what preparation of vaccine therapy is most effective for treating melanoma. PURPOSE: Randomized phase II trial to study the effectiveness of tyrosinase/gp100 peptide vaccine in treating patients who have stage II melanoma that can be removed by surgery.

Conditions

Melanoma (Skin)

Keywords

stage II melanoma

Interventions

gp100 antigen BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

sargramostim BIOLOGICAL

tyrosinase peptide BIOLOGICAL

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven stage IIA or stage IIB resectable cutaneous melanoma rendered disease free Clinically uninvolved lymph nodes by physical examination OR Pathologically uninvolved lymph nodes or sentinel lymph nodes after either complete node dissection or selective lymphadenectomy, respectively No evidence of metastatic disease within 28 days prior to definitive surgery HLA-A2 positive PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Hematopoietic: No coagulation disorders No significant hematologic abnormality Hepatic: Bilirubin no greater than 2.0 mg/dL No significant liver abnormality Renal: Creatinine no greater than 2.0 mg/dL No significant kidney abnormality Cardiovascular: No major medical illness of the cardiovascular system Pulmonary: No major medical illness of the respiratory system Other: No known allergic reaction to Montanide ISA-51 or sargramostim (GM-CSF) No major systemic infections Not pregnant or nursing HIV negative Hepatitis B surface antigen negative Hepatitis C antibody negative No prior uveitis or autoimmune inflammatory eye disease No active autoimmune disease No other malignancy within past 5 years PRIOR CONCURRENT THERAPY: At least 1 month since prior adjuvant therapy or any other therapy for cancer Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent steroid therapy Radiotherapy: At least 1 month since prior radiotherapy Surgery: See Disease Characteristics

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

Sponsors & Collaborators

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

Study Sites (2)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

MeSH Terms

Conditions

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; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeffrey S. Weber, MD, PhD

  University of Southern California

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 22, 2004
• Study Start: March 1, 1998
• Primary Completion: September 1, 2001
• Study Completion: November 1, 2002
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (2)