Expired Study
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Chicago, Illinois 60606


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00005949


Primary Contact:

Principal Investigator
John Roberts
Cancer and Leukemia Group B


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60606
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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