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
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 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 August 21, 2014