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Trial for the Evaluation of the Effect of Systemic Low-dose Interleukin-2 (IL-2) on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With High Risk Melanoma (MEL36)

This study has been completed.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00928902
First received: June 24, 2009
Last updated: October 20, 2010
Last verified: October 2010

June 24, 2009
October 20, 2010
November 1999
April 2001   (final data collection date for primary outcome measure)
To evaluate the effect of systemic low-dose IL-2 on the immunogenicity of a vaccine comprising synthetic melanoma peptides plus GM-CSF-in-adjuvant. [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00928902 on ClinicalTrials.gov Archive Site
Changes in disease, analysis of melanoma antigen (gp100, tyrosinase, MART-1) expression on melanoma cells from metastatic sites, Vitiligo. [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Trial for the Evaluation of the Effect of Systemic Low-dose Interleukin-2 (IL-2) on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With High Risk Melanoma
Pilot Phase II Trial for the Evaluation of the Effect of Systemic Low-dose IL-2 on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant, in Patients With High Risk Melanoma

This clinical pilot study will test the hypothesis that systemic low-dose IL-2 therapy significantly enhances the immunologic efficacy of a vaccine comprising melanoma peptides plus GM-CSF-in-adjuvant.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
  • Drug: low-dose IL-2
    low-dose IL-2, administered daily for 6 weeks, to begin either at week 1 (group 1) or week 4 (group 2)
  • Biological: melanoma vaccine
    six melanoma vaccines given over a 6-week period
  • Active Comparator: Peptides with GM-CSF-in-adjuvant, with upfront IL-2
    Each of the peptides plus tetanus toxoid peptide, plus GM-CSF in adjuvant, administered subcutaneously and intradermally. Systemic low-dose IL-2 will be administered daily for 6 weeks, beginning at week 1 and ending at week 7.
    Interventions:
    • Drug: low-dose IL-2
    • Biological: melanoma vaccine
  • Active Comparator: Peptides plus GM-CSF-in-adjuvant, delayed IL-2

    Peptides plus GMCSF-in-adjuvant, with delayed IL-2.

    Each of the peptides plus tetanus toxoid peptide, plus GM-CSF in adjuvant, administered subcutaneously and intradermally. Systemic low-dose IL-2 will be administered daily for 6 weeks, beginning at week 4 and ending at week 10.

    Interventions:
    • Drug: low-dose IL-2
    • Biological: melanoma vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
March 2005
April 2001   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who have been diagnosed, by cytologic or histologic examination, with AJCC stage IIB, stage III or resected stage IV melanoma.
  • Patients with up to 2 brain metastases less than or equal to 2 cm that have been surgically removed or treated successfully with the gamma-knife are eligible. Surgical resections must have been performed within 6 months prior to entry.
  • All patients must have:

    1. ECOG performance status 0-1, and,
    2. Ability and willingness to give informed consent.
  • Laboratory parameters as follows:

    • HLA-A1, A2 or A3 (+)
    • gp100 (+) and/or tyrosinase (+) tumor cells
    • ANC > 1000/mm3, and Platelets > 100,000 and Hgb > 9
    • Hepatic: AST and ALT up to 2.5 x upper limits of normal (ULN), Bilirubin up to 2.5 x ULN, Alkaline phosphatase up to 2.5 x ULN
    • Renal: Creatinine up to 1.5 x ULN
    • Serology: HIV negative, Hepatitis C negative

Exclusion criteria:

  • Patients who are currently receiving cytotoxic Chemotherapy or radiation or who have received that therapy within the preceding 4 weeks.
  • Patients with known or suspected allergies to any component of the vaccine.
  • Patients receiving the following medications at study entry or within the preceding 30 days are excluded:

    • Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents)
    • Allergy desensitization injections
    • Corticosteroids, administered parenterally or orally - topical corticosteroids are acceptable
  • Any growth factors, Interleukin 2, Interferon alfa.
  • Prior melanoma vaccinations will not be an exclusion criteria if given more than 8 weeks previously, but will be recorded, and data analysis will take this into account.
  • Other investigational drugs or investigational therapy also will not necessarily be an exclusion criteria, but will similarly be recorded and taken into account during data analysis.
  • Pregnancy or the possibility of becoming pregnant during vaccine administration.

    • Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the first vaccine dose.
    • Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination.
    • This is consistent with existing standards of practice for vaccine and chemotherapy protocols.
  • Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
  • Patients classified according to the New York Heart Association classification system as having Class II, III or IV heart disease.
  • Patients with active connective tissue disease requiring medication, or other severe autoimmune disease.
  • Patients who are actively hyperthyroid.
  • Patients with uncontrolled diabetes.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00928902
8515
Yes
Craig L Slingluff MD, University of Virginia
University of Virginia
Not Provided
Principal Investigator: Craig L Slingluff, MD University of Virginia
University of Virginia
October 2010

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