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

Not Applicable

Completed

• Conditions: Melanoma
• Interventions: Drug: Saline; Drug: GM-CSF-in-adjuvant; Drug: Montanide ISA-51; Biological: GM-CSF and Montanide ISA-51

• Registration Number: NCT00912574
• Lead Sponsor: University of Virginia

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 node biopsy as definitive surgical therapy.

In Stage 1: Patients will be injected with a 1 ml emulsion containing GM-CSF in saline plus 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. 1 ml saline

2. GM-CSF in 1 ml saline

3. an emulsion of Montanide ISA-51 adjuvant and saline

4. an emulsion of GM-CSF in saline plus ml Montanide ISA-51 adjuvant. All vaccines will be administered intradermally. After the injection, each patient will undergo wide excision of the melanoma site, with or without sentinel node biopsy, as clinically indicated.

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2008-07
• Status Verified: 2009-06
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-02
• Last Update Submitted: 2009-06-02
• Study First Posted: 2009-06-03
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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:

  1. Karnofsky performance of 80% or higher
  2. ECOG performance status of 0 or 1
  3. Ability and willingness to give informed consent

• Laboratory parameters as follows:

  1. ANC: 90% of lower limit of normal (LLN) to 120% of upper limit of normal (ULN)

  2. Platelets: 100-500 x 103/uL

  3. Hgb: 90% LLN to 120% ULN

  4. Hepatic:

     1. AST, ALT, Bilirubin, and Alk phos within normal limits,
     2. LDH up to 1.2 x ULN

  5. Renal:

     1. Creatinine up to 1.5 x ULN

• Age 18-85 years at the time of study entry.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saline	Saline	first of 4 arms: injection: 1 ml saline
GM-CSF	GM-CSF-in-adjuvant	Second of 4 arms: injection: specified dose of GM-CSF in 1 ml saline
0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline	Montanide ISA-51	Third of 4 arms: injection: 0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline
GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant	GM-CSF and Montanide ISA-51	Fourth of 4 arms: injection: specified dose of GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant

Primary Outcome Measures

Name	Time	Method
Number of dendritic cells (total and mature) accumulating in the dermis after administration of the adjuvant
Proportion of the sentinel node occupied by dendritic cells (total and mature)

Secondary Outcome Measures

Name	Time	Method
Time to maximal dendritic cell infiltration into the dermis

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States