Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: July 5, 2000
Last updated: January 15, 2013
Last verified: January 2013

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical response rate (CR or PR) [ Time Frame: From the start of treatment until disease progression/recurrence, assessed up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response duration [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used to estimate duration of response.

  • Progression-free intervals [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used to estimate time to progression.

  • Immunologic response rate using ELISPOT assay [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Described in terms of frequency and kinetics. Agreement between clinical and immunological response will be measured using the kappa coefficient.

Enrollment: 50
Study Start Date: March 2001
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00005949

United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
Principal Investigator: John Roberts Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00005949     History of Changes
Other Study ID Numbers: NCI-2012-02337, CLB-509901, U10CA031946, CDR0000067886
Study First Received: July 5, 2000
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Analgesics, Non-Narcotic
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2014