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

Melanoma Clinical Trial

— MEL36  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928902
• Other study ID #: 8515
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2009
• Last updated: October 20, 2010
• Start date: November 1999
• Est. completion date: March 2005

Study information

• Verified date: October 2010
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2005
• Est. primary completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			Yes
Secondary	Changes in disease, analysis of melanoma antigen (gp100, tyrosinase, MART-1) expression on melanoma cells from metastatic sites, Vitiligo.			Yes