Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

Phase 2

Completed

• Conditions: Recurrent Melanoma; Stage IV Melanoma
• Interventions: Biological: aldesleukin; Other: laboratory biomarker analysis

• Registration Number: NCT00005949
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study First Submitted: 2000-07-05
• Study Start: 2001-03
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (gp100:209-217, aldesleukin )	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.
Treatment (gp100:209-217, aldesleukin )	laboratory biomarker analysis	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.

Primary Outcome Measures

Name	Time	Method
Clinical response rate (CR or PR)	From the start of treatment until disease progression/recurrence, assessed up to 3 years

Secondary Outcome Measures

Name	Time	Method
Response duration	Up to 3 years	The Kaplan-Meier method will be used to estimate duration of response.
Progression-free intervals	Up to 3 years	The Kaplan-Meier method will be used to estimate time to progression.
Immunologic response rate using ELISPOT assay	Up to 3 years	Described in terms of frequency and kinetics. Agreement between clinical and immunological response will be measured using the kappa coefficient.

Trial Locations

Locations (1)

Cancer and Leukemia Group B; 🇺🇸 Chicago, Illinois, United States