Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma

NCT00104845 | Completed Phase 1

• 3 other identifiers: 03-007P30CA008748MSKCC-IRB-03007
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from DNA may make the body build an effective immune response to kill tumor cells. PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage II melanoma; stage III melanoma; stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• safety and feasibility

  2 years

Secondary Outcomes (2)

• maximum tolerated dose

  2 years

• antibody and T-cell response

  2 years

Study Arms (2)

human gp100 DNA vaccine

EXPERIMENTAL

Patients receive human gp100 DNA vaccine intramuscularly (IM) once in weeks 1, 4, and 7. Patients then receive mouse gp100 DNA vaccine IM once in weeks 10, 13, and 16.

Biological: human gp100 plasmid DNA vaccine; Biological: mouse gp100 plasmid DNA vaccine

mouse gp100 DNA vaccine

EXPERIMENTAL

Patients receive mouse gp100 DNA vaccine IM once in weeks 1, 4, and 7. Patients then receive human gp100 DNA vaccine IM once in weeks 10, 13, and 16

Biological: human gp100 plasmid DNA vaccine; Biological: mouse gp100 plasmid DNA vaccine

Interventions

human gp100 plasmid DNA vaccine BIOLOGICAL

human gp100 DNA vaccine; mouse gp100 DNA vaccine

mouse gp100 plasmid DNA vaccine BIOLOGICAL

human gp100 DNA vaccine; mouse gp100 DNA vaccine

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed malignant melanoma * Stage IIB, IIC, III, or IV disease * Patients with stage III or IV disease who are free of disease after surgical resection\* are eligible * Patients free of disease after surgical resection\* must have refused high-dose interferon alfa OR experienced recurrent disease during prior treatment with interferon alfa NOTE: \*Patients who underwent surgical resection must have had the surgery within the past year * HLA-A0201 positive * No detectable brain metastases PATIENT CHARACTERISTICS: Age * Any age Performance status * Karnofsky 80-100% Life expectancy * Not specified Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * No active bleeding Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Albumin ≥ 3.5 g/dL * AST and ALT ≤ 2.5 times ULN * Lactate dehydrogenase ≤ 2 times ULN * No clinical history of hepatitis B or C Renal * Creatinine ≤ 2.0 mg/dL Immunologic * No clinical history of HIV * No clinical history of HTLV-1 * No active infection requiring antibiotics within the past 72 hours * No history of collagen vascular, rheumatologic, or other autoimmune disorder * No grade 1 fever within the past 72 hours Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Weight ≥ 25 kg * No serious underlying medical condition that would preclude study participation * No preexisting uveal or choroidal eye disease PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * More than 4 weeks since prior immunotherapy * No prior immunization with any class of vaccine containing gp100, including whole cell, shed antigen, or cell lysate vaccines Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy * No concurrent corticosteroids that would preclude study participation Radiotherapy * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics Other * Recovered from all prior therapy * No other concurrent medication that would preclude study participation * No other concurrent investigational agents * No other concurrent systemic therapy

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Melanoma

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

• Jedd D. Wolchok, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: September 1, 2004
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

US (1)