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

NCT ID: NCT00928902

Last Updated: 2010-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30
• Study Completion Date: 2005-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

low-dose IL-2

Intervention Type: DRUG

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

melanoma vaccine

Intervention Type: BIOLOGICAL

six melanoma vaccines given over a 6-week period

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.

Group Type: ACTIVE_COMPARATOR

low-dose IL-2

Intervention Type: DRUG

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

melanoma vaccine

Intervention Type: BIOLOGICAL

six melanoma vaccines given over a 6-week period

Interventions

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)

Intervention Type: DRUG

melanoma vaccine

six melanoma vaccines given over a 6-week period

Intervention Type: BIOLOGICAL

Eligibility 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

University of Virginia

Principal Investigators

Craig L Slingluff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Other Identifiers

8515

Identifier Type: -

Identifier Source: org_study_id