Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00104845
First received: March 3, 2005
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: human gp100 plasmid DNA vaccine Biological: mouse gp100 plasmid DNA vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- safety and feasibility [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- maximum tolerated dose [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- antibody and T-cell response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 19 |
| Study Start Date: | September 2004 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: human gp100 DNA vaccine
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 |
|
Experimental: mouse gp100 DNA vaccine
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 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104845
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Study Chair: | Jedd D. Wolchok, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00104845 History of Changes |
| Other Study ID Numbers: | 03-007, P30CA008748, MSKCC-IRB-03007 |
| Study First Received: | March 3, 2005 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
stage II melanoma stage III melanoma stage IV melanoma recurrent melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 19, 2013