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Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

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ClinicalTrials.gov Identifier: NCT00005949
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 16, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE July 5, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date January 16, 2013
Study Start Date  ICMJE March 2001
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
Clinical response rate (CR or PR) [ Time Frame: From the start of treatment until disease progression/recurrence, assessed up to 3 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00005949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
  • Response duration [ Time Frame: Up to 3 years ]
    The Kaplan-Meier method will be used to estimate duration of response.
  • Progression-free intervals [ Time Frame: Up to 3 years ]
    The Kaplan-Meier method will be used to estimate time to progression.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
Official Title  ICMJE Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma
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 Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Melanoma
  • Stage IV Melanoma
Intervention  ICMJE
  • 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
Study Arms 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.
Interventions:
  • Biological: aldesleukin
  • Biological: gp100:209-217(210M) peptide vaccine
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2013)
50
Original Enrollment  ICMJE Not Provided
Study Completion Date Not Provided
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00005949
Other Study ID Numbers  ICMJE NCI-2012-02337
CLB-509901
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000067886 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Roberts Cancer and Leukemia Group B
PRS Account National Cancer Institute (NCI)
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP