Clinical trial NCT00928902: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: melanoma
vaccine
peptides
adjuvant
immunogenicity
stage IIB, stage III or resected stage IV
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2009-06-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* 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.

Primary outcomes:
measure: 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:
measure: Changes in disease, analysis of melanoma antigen (gp100, tyrosinase, MART-1) expression on melanoma cells from metastatic sites, Vitiligo.
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: Craig L Slingluff, MD
role: PRINCIPAL_INVESTIGATOR
References: