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
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: low-dose IL-2
Biological: melanoma vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Changes in disease, analysis of melanoma antigen (gp100, tyrosinase, MART-1) expression on melanoma cells from metastatic sites, Vitiligo. [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: November 1999
Study Completion Date: March 2005
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928902

Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Craig L Slingluff, MD University of Virginia
  More Information

No publications provided

Responsible Party: Craig L Slingluff MD, University of Virginia
ClinicalTrials.gov Identifier: NCT00928902     History of Changes
Other Study ID Numbers: 8515
Study First Received: June 24, 2009
Last Updated: October 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
melanoma
vaccine
peptides
adjuvant
immunogenicity
stage IIB, stage III or resected stage IV

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014