Working... Menu

Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005949
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 16, 2013
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Recurrent Melanoma Stage IV Melanoma Biological: aldesleukin Biological: gp100:209-217(210M) peptide vaccine Other: laboratory biomarker analysis Phase 2

Detailed Description:


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.


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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma
Study Start Date : March 2001
Actual Primary Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Aldesleukin

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.
Biological: aldesleukin
Given SC
Other Names:
  • IL-2
  • Proleukin
  • 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)

Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  1. Clinical response rate (CR or PR) [ Time Frame: From the start of treatment until disease progression/recurrence, assessed up to 3 years ]

Secondary Outcome Measures :
  1. Response duration [ Time Frame: Up to 3 years ]
    The Kaplan-Meier method will be used to estimate duration of response.

  2. Progression-free intervals [ Time Frame: Up to 3 years ]
    The Kaplan-Meier method will be used to estimate time to progression.

  3. Immunologic response rate using ELISPOT assay [ Time Frame: Up to 3 years ]
    Described in terms of frequency and kinetics. Agreement between clinical and immunological response will be measured using the kappa coefficient.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005949

Layout table for location information
United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: John Roberts Cancer and Leukemia Group B

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00005949     History of Changes
Other Study ID Numbers: NCI-2012-02337
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000067886 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents