Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

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

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 Overview

• Status: Completed
• Conditions: Recurrent Melanoma; Stage IV Melanoma
• Intervention / Treatment: Other: laboratory biomarker analysis; Biological: aldesleukin; Biological: gp100:209-217(210M) peptide vaccine

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: laboratory biomarker analysis; Correlative studies; Biological: aldesleukin; Given SC; Other Names: Proleukin; IL-2; recombinant human interleukin-2; recombinant interleukin-2; Biological: gp100:209-217(210M) peptide vaccine; Given SC; Other Names: G9 209-2M; gp100:209-217(210M)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: John Roberts, Cancer and Leukemia Group B

Study record dates

Study Major Dates

• Study Start: March 1, 2001
• Primary Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: July 5, 2000
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): January 16, 2013
• Last Update Submitted That Met QC Criteria: January 15, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antineoplastic Agents; Aldesleukin; Interleukin-2
• Other Study ID Numbers: NCI-2012-02337; U10CA031946 (U.S. NIH Grant/Contract); CLB-509901; CDR0000067886 (Registry Identifier: PDQ (Physician Data Query))