Status:
COMPLETED
Evaluation of the Effects of Local Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes: MEL38
Lead Sponsor:
University of Virginia
Conditions:
Melanoma
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Goal: To characterize the cellular events that occur in vivo after vaccination with an emulsion of GMCSF-in-adjuvant. Design: Open-label, single dose study in two stages.
Detailed Description
Regimen: Each injection will be administered to patients with clinical stage I or II melanoma, who have had complete excision of a primary melanoma, but prior to wide excision with or without sentinel...
Eligibility Criteria
Inclusion
- Patients who have been diagnosed, by histologic and clinical examination, with resected AJCC stage I or II melanoma.
- Patients who have any evidence of metastasis will not be eligible.
- All patients must have:
- Karnofsky performance of 80% or higher
- ECOG performance status of 0 or 1
- Ability and willingness to give informed consent
- Laboratory parameters as follows:
- ANC: 90% of lower limit of normal (LLN) to 120% of upper limit of normal (ULN)
- Platelets: 100-500 x 103/uL
- Hgb: 90% LLN to 120% ULN
- Hepatic:
- AST, ALT, Bilirubin, and Alk phos within normal limits,
- LDH up to 1.2 x ULN
- Renal:
- Creatinine up to 1.5 x ULN
- Age 18-85 years at the time of study entry.
Exclusion
- Patients who are currently receiving cytotoxic chemotherapy, interferon, or radiation or who have received this therapy within the preceding 12 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 4 weeks 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 or other interleukins.
- 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 injection.
- 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 as having Class III or IV heart disease.
- Patients with serious symptomatic active pulmonary disease, with pleural effusions, or with a history of pulmonary edema.
- Patients who have systemic autoimmune disease with visceral involvement.
- Patients with clinically apparent skin infection or other clinically evident inflammation involving the skin adjacent to the melanoma biopsy scar.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00912574
Start Date
June 1 2004
Last Update
June 3 2009
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908