Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma
18 Years
N/A
Both
Recurrent Melanoma, Stage IV Melanoma
Trial Information
Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma
PRIMARY OBJECTIVES:
I. Determine clinical response rates in patients with advanced melanoma treated with
gp100:209-217(210M) melanoma vaccine and low-dose interleukin-2.
II. Assess response duration and progression-free intervals in these patients receiving this
treatment.
OUTLINE:
Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 subcutaneously (SC) on
day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence
of unacceptable toxicity or disease progression. Patients with a complete response (CR)
receive 3 additional courses after achieving CR.
Patients are followed every 9 weeks for 3 years or until disease recurrence.
PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3.5
years.
Inclusion Criteria:
- Histologically or cytologically confirmed cutaneous melanoma with clinical evidence
of distant, metastatic, unresectable regional lymphatic, or extensive in-transit
recurrent disease
- HLA-A2*0201 positive by genotyping
- Measurable disease as defined by the following:
- At least 1 lesion accurately measured in at least 1 dimension
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
- Lesions considered intrinsically nonmeasurable include:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- Lesions situated in a previously irradiated area
- No ocular or mucosal melanoma
- No prior or concurrent liver or brain metastases
- Performance status - ECOG 0-1
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
- LDH normal
- Bilirubin normal
- AST no greater than 2.5 times upper limit of normal
- Creatinine normal
- No congestive heart failure, angina, or symptomatic cardiac arrhythmia
- No myocardial infarction within the past 6 months
- No severe chronic pulmonary disease
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No primary or secondary immunodeficiency or autoimmune disease
- No currently active second malignancy (e.g., patient has completed therapy and is
considered unlikely to have recurrence within 1 year) other than nonmelanoma skin
cancer
- At least 4 weeks since prior immunotherapy
- No prior interleukin-2
- No prior whole cell or gp100:209-217(210M)-targeted melanoma vaccine
- No other concurrent cytokines or growth factors
- At least 4 weeks since prior chemotherapy
- At least 1 month since prior systemic corticosteroids
- No concurrent systemic, inhaled, or topical corticosteroids
- At least 1 month since other prior immunosuppressive medication
- No antihypertensive medications from 1 day prior until 2 days after first course
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical response rate (CR or PR)
Outcome Time Frame:
From the start of treatment until disease progression/recurrence, assessed up to 3 years
Safety Issue:
No
Principal Investigator
John Roberts
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer and Leukemia Group B
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02337
NCT ID:
NCT00005949
Start Date:
March 2001
Completion Date:
Related Keywords:
- Recurrent Melanoma
- Stage IV Melanoma
- Melanoma
Name | Location |
|---|---|
| Cancer and Leukemia Group B | Chicago, Illinois 60606 |
