Status:
COMPLETED
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
Lead Sponsor:
University of Virginia
Conditions:
Melanoma
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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
- 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:
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00928902
Start Date
November 1 1999
End Date
March 1 2005
Last Update
October 21 2010
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