Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

NCT ID: NCT00005949

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31

Brief 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

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.

Conditions

Recurrent Melanoma; Stage IV Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (gp100:209-217, aldesleukin )

Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 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 CR receive 3 additional courses after achieving CR.

Group Type: EXPERIMENTAL

aldesleukin

Intervention Type: BIOLOGICAL

Given SC

gp100:209-217(210M) peptide vaccine

Intervention Type: BIOLOGICAL

Given SC

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

aldesleukin

Given SC

Intervention Type: BIOLOGICAL

gp100:209-217(210M) peptide vaccine

Given SC

Intervention Type: BIOLOGICAL

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

IL-2; Proleukin; recombinant human interleukin-2; recombinant interleukin-2; G9 209-2M; gp100:209-217(210M)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Roberts

Role: PRINCIPAL_INVESTIGATOR

Cancer and Leukemia Group B

Locations

Cancer and Leukemia Group B

Chicago, Illinois, United States

Countries

United States

Other Identifiers

CLB-509901

Identifier Type: -

Identifier Source: secondary_id

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000067886

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02337

Identifier Type: -

Identifier Source: org_study_id