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Therapeutic Areas: Oncology | Dermatology/Plastic Surgery
Disease Category: Skin Cancer

Trial Information

Evaluation of the Effects of Local GM-CSF-in-adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes ( HIC # 8380)

This is an open-label, single dose study in two stages. To characterize the cellular events that occur in vivo after vaccination with an emulsion of GMCSF-in-adjuvant.

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 and sentinel node biopsy as definitive surgical therapy.

In Stage 1:
Patients will be injected with a 1 ml emulsion containing 110 µ GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.

In Stage 2:
Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar:

• 1 ml saline
• 110 µ GM-CSF in 1 ml saline
• an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
• an emulsion of 110 µ GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant

All vaccines will be administered intradermally. After the injection, each patient will undergo wide excision of the melanoma site, plus sentinel node biopsy.

Population:
Criteria for inclusion include age 18 to 85, and the diagnosis of clinical stage I or II melanoma. The number of patients accrued will be 56, with 24 in stage I and 32 in stage II.

After each injection, the patients will undergo wide excision of the melanoma and sentinel node biopsy, and portions of the skin from the injection site, and of the sentinel node, will be saved for research use. The timing of the injection prior to surgery will be as follows:

Inclusion criteria:

• 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, platelets, and Hgb within normal limits
  • Hepatic: -AST, ALT, Bilirubin, Alk phos, and LDH within normal limits
  • Renal: -Creatinine up to 1.5 x ULN
• Age 18-85 years at the time of study entry

Lori Elder, Assistant Director
University of Virginia
School of Medicine
Clinical Trials Office
One Morton Drive, Suite 200
Charlottesville, VA 22903
Phone: 434-924-8530
Fax: 434-243-5999
EMail: uvaclintrials@virginia.edu

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