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Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrent Melanoma; Stage IV Melanoma

Intervention: aldesleukin (Biological); gp100:209-217(210M) peptide vaccine (Biological); laboratory biomarker analysis (Other)

Phase: Phase 2

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
John Roberts, Principal Investigator, Affiliation: Cancer and Leukemia Group B

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

Clinical Details

Official title: Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical response rate (CR or PR)

Secondary outcome:

Response duration

Progression-free intervals

Immunologic response rate using ELISPOT assay

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Starting date: March 2001
Last updated: January 15, 2013

Page last updated: August 23, 2015

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