Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma

NCT00037037 | Unknown Phase 1

• 4 other identifiers: CDR0000069357CPMC-IRB-13824LUDWIG-LUD00-025NCI-G02-2068
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Interventions

MAGE-10.A2 BIOLOGICAL

MART-1 antigen BIOLOGICAL

NY-ESO-1 peptide vaccine 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 confirmed high-risk stage III or IV melanoma * Stage III disease less than 6 months after surgical resection * Completed prior interferon alfa therapy OR * Progressive disease or major adverse events during prior interferon alfa therapy * Stage III disease at least 6 months after surgical resection * Declined, failed, or completed prior standard therapy * Stage IV disease * Declined, failed, or completed prior standard therapy * HLA-A2 positive * No CNS metastases unless treated and stable PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 80-100% Life expectancy: * At least 4 months Hematopoietic: * Neutrophil count at least 1,500/mm3 * Lymphocyte count at least 500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg) * No bleeding disorder Hepatic: * Bilirubin no greater than 2.0 mg/dL * No hepatitis B or C positivity Renal: * Creatinine no greater than 1.8 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * HIV negative * No other serious illness * No serious infection requiring antibiotics * No history of immunodeficiency disease or autoimmune disease * No psychiatric or addictive disorder that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior bone marrow or stem cell transplantation * At least 4 weeks since prior immunotherapy or biologic therapy * No other concurrent immunotherapy or biologic therapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * No concurrent chemotherapy Endocrine therapy: * No concurrent systemic corticosteroids * No concurrent steroids except topical or inhalational steroids * Concurrent hormonal therapy allowed Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics * At least 4 weeks since prior surgery Other: * At least 4 weeks since prior investigational agents * Concurrent noncytotoxic anticancer therapy allowed * No concurrent immunosuppressive therapy * No concurrent antihistamines * No concurrent non-steroidal anti-inflammatory drugs except in low doses for prevention of an acute cardiovascular event or pain control

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

Sponsors & Collaborators

• Herbert Irving Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

MART-1 Antigen; 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

Intervention Hierarchy (Ancestors)

Melanoma-Specific Antigens; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors

Study Officials

• Kyriakos P. Papadopoulos, MD

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 13, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Last Updated: December 18, 2013

Record last verified: 2004-05

Locations

US (1)