Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma

NCT00031733 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000069220 (10M-01-1)LAC-USC-10M011LAC-USC-IRB-013030NCI-5506
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

Conditions

Intraocular Melanoma; Melanoma (Skin)

Keywords

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

Interventions

MART-1 antigen BIOLOGICAL

gp100 antigen BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

recombinant interleukin-12 BIOLOGICAL

sargramostim BIOLOGICAL

tyrosinase peptide BIOLOGICAL

alum adjuvant DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of stage IIB, IIC, III, or IV cutaneous melanoma OR stage III or IV ocular or mucosal melanoma * Resected or rendered disease-free * HLA-A2.1-positive by standard cytotoxicity assay * Tumor tissue must be available for analysis of gp100 staining and tyrosinase and MART-1 expression by immunohistochemistry * Must be positive for at least 1 antigen * Failed, ineligible for, or refused prior interferon alfa PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL * No bleeding disorder Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT/SGPT no greater than 2.5 times normal * No coagulation disorder * Hepatitis surface antigen B negative * Hepatitis C negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No major cardiovascular illness Pulmonary: * No major respiratory illness Immunologic: * No prior uveitis * No prior autoimmune inflammatory eye disease * No immune hemolytic anemia * No other active autoimmune disease Other: * HIV negative * No major gastrointestinal illness * No other malignancy within the past 5 years except squamous cell skin cancer or carcinoma in situ of the cervix curatively treated at least 30 days ago * No major systemic infection (e.g., pneumonia or sepsis) * No other major medical illness * No prior allergic reaction to Montanide ISA-51 or alum adjuvant * No requirement for steroid therapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or MART-1:26-35 (27L) peptides Chemotherapy: * At least 1 month since prior adjuvant chemotherapy for this disease * No concurrent adjuvant chemotherapy Endocrine therapy: * No concurrent steroids Radiotherapy: * At least 1 month since prior radiotherapy for this disease * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * At least 1 month since other prior therapy, including adjuvant therapy, for this disease * No other concurrent therapy, including adjuvant therapy

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 (1)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

MART-1 Antigen; incomplete Freund's adjuvant; Interleukin-12 Subunit p35; sargramostim; Aluminum Hydroxide; Chemotherapy, Adjuvant

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

Intervention Hierarchy (Ancestors)

Melanoma-Specific Antigens; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors; Interleukin-12; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes; Combined Modality Therapy; Therapeutics; Drug Therapy

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: March 8, 2002
• First Posted: January 27, 2003
• Study Start: February 1, 2002
• Primary Completion: December 1, 2004
• Study Completion: November 1, 2007
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)