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

NCT00928902 | Completed Phase 2 DMC

• 1 other identifier: 8515
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Melanoma

Keywords

melanoma; vaccine; peptides; adjuvant; immunogenicity; stage IIB, stage III or resected stage IV

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Changes in disease, analysis of melanoma antigen (gp100, tyrosinase, MART-1) expression on melanoma cells from metastatic sites, Vitiligo.

Study Arms (2)

Peptides with GM-CSF-in-adjuvant, with upfront IL-2

ACTIVE COMPARATOR

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; Biological: melanoma vaccine

Peptides plus GM-CSF-in-adjuvant, delayed IL-2

ACTIVE COMPARATOR

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; Biological: melanoma vaccine

Interventions

low-dose IL-2 DRUG

low-dose IL-2, administered daily for 6 weeks, to begin either at week 1 (group 1) or week 4 (group 2)

Peptides plus GM-CSF-in-adjuvant, delayed IL-2; Peptides with GM-CSF-in-adjuvant, with upfront IL-2

melanoma vaccine BIOLOGICAL

six melanoma vaccines given over a 6-week period

Peptides plus GM-CSF-in-adjuvant, delayed IL-2; Peptides with GM-CSF-in-adjuvant, with upfront IL-2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ECOG performance status 0-1, and,
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Virginia: lead

MeSH Terms

Conditions

Melanoma

Interventions

Interleukin-2; polyvalent melanoma cell vaccine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Craig L Slingluff, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 26, 2009
• Study Start: November 1, 1999
• Primary Completion: April 1, 2001
• Study Completion: March 1, 2005
• Last Updated: October 21, 2010

Record last verified: 2010-10