Melanoma Clinical Trial

Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

Summary

Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Melanoma vaccine plus interleukin-2 may kill more cancer cells

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT00005949

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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Cancer and Leukemia Group B
Chicago Illinois, 60606, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT00005949

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

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