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

This study has been completed.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00912574
First received: June 1, 2009
Last updated: June 2, 2009
Last verified: June 2009

June 1, 2009
June 2, 2009
June 2004
July 2008   (final data collection date for primary outcome measure)
  • Number of dendritic cells (total and mature) accumulating in the dermis after administration of the adjuvant [ Designated as safety issue: Yes ]
  • Proportion of the sentinel node occupied by dendritic cells (total and mature) [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00912574 on ClinicalTrials.gov Archive Site
Time to maximal dendritic cell infiltration into the dermis [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Evaluation of the Effects of Local GM-CSF-in-Adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
  • Drug: GM-CSF-in-adjuvant

    For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of 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 at one of two time points:

    1. 1 ml saline
    2. specified dose of GM-CSF in 1 ml saline
    3. an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
    4. an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
  • Drug: Montanide ISA-51

    For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of 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 at one of two time points:

    1. 1 ml saline
    2. specified dose of GM-CSF in 1 ml saline
    3. an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
    4. an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
  • Biological: GM-CSF and Montanide ISA-51

    For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of 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 at one of two time points:

    1. 1 ml saline
    2. specified dose of GM-CSF in 1 ml saline
    3. an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
    4. an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
  • Drug: Saline

    For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of 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 at one of two time points:

    1. 1 ml saline
    2. specified dose of GM-CSF in 1 ml saline
    3. an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
    4. an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
  • Active Comparator: Saline
    first of 4 arms: injection: 1 ml saline
    Intervention: Drug: Saline
  • Active Comparator: GM-CSF
    Second of 4 arms: injection: specified dose of GM-CSF in 1 ml saline
    Intervention: Drug: GM-CSF-in-adjuvant
  • Active Comparator: 0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline
    Third of 4 arms: injection: 0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline
    Intervention: Drug: Montanide ISA-51
  • Active Comparator: GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant
    Fourth of 4 arms: injection: specified dose of GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant
    Intervention: Biological: GM-CSF and Montanide ISA-51
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
Not Provided
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00912574
8380
No
Craig L Slingluff MD, University of Virginia
University of Virginia
Not Provided
Principal Investigator: Craig L Slingluff, MD University of Virginia
University of Virginia
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP