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

Injection of AJCC Stage IIB, IIC, III, and IV Melanoma Patients With Human and Mouse gp100 DNA: A Phase I Trial to Assess Safety and Immune Response

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00104845
Enrollment
19
Registered
2005-03-04
Start date
2004-09-30
Completion date
2011-09-30
Last updated
2013-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

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.

Detailed description

OBJECTIVES: Primary * Determine the safety and feasibility of vaccination with human and mouse gp100 DNA in patients with stage IIB, IIC, III, or IV melanoma. * Determine the maximum tolerated dose of this regimen in these patients. * Compare the antibody and T-cell response in patients treated with two different vaccination schedules. Secondary * Assess antitumor response in patients treated with this regimen. OUTLINE: This is a randomized, crossover, dose-escalation study. Patients are randomized to 1 of 2 treatment arms. * Arm I: 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. * Arm II: 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. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 6-9 patients (at least 3 per treatment arm) receive escalating doses of human and mouse gp100 DNA vaccines until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 9 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed at 3 weeks and then annually for 15 years. PROJECTED ACCRUAL: Approximately 18-27 patients will be accrued for this study within 6-9 months.

Interventions

BIOLOGICALhuman gp100 plasmid DNA vaccine

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
safety and feasibility2 years

Secondary

MeasureTime frame
maximum tolerated dose2 years
antibody and T-cell response2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026