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

Completed · Not applicable

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00912574

Run by

University of Virginia

People needed

29

Starts

2004-06-01

Last updated by the study team

2009-06-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.