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

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
human gp100 plasmid DNA vaccine
mouse gp100 plasmid DNA vaccine
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

human gp100 DNA vaccine

mouse gp100 DNA vaccine

Arm Description

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.

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

Outcomes

Primary Outcome Measures

safety and feasibility

Secondary Outcome Measures

maximum tolerated dose
antibody and T-cell response

Full Information

First Posted
March 3, 2005
Last Updated
March 11, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00104845
Brief Title
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
human gp100 DNA vaccine
Arm Type
Experimental
Arm Description
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 Title
mouse gp100 DNA vaccine
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
human gp100 plasmid DNA vaccine
Intervention Type
Biological
Intervention Name(s)
mouse gp100 plasmid DNA vaccine
Primary Outcome Measure Information:
Title
safety and feasibility
Time Frame
2 years
Secondary Outcome Measure Information:
Title
maximum tolerated dose
Time Frame
2 years
Title
antibody and T-cell response
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jedd D. Wolchok, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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