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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 (MEL38)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00912574
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
University of Virginia

Study Description
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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.


Condition or disease Intervention/treatment Phase
Melanoma Drug: GM-CSF-in-adjuvant Drug: Montanide ISA-51 Biological: GM-CSF and Montanide ISA-51 Drug: Saline Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Local GM-CSF-in-Adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes
Study Start Date : June 2004
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Saline
first of 4 arms: injection: 1 ml saline
 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: GM-CSF
Second of 4 arms: injection: specified dose of GM-CSF in 1 ml saline
 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
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
 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
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of dendritic cells (total and mature) accumulating in the dermis after administration of the adjuvant
  2. Proportion of the sentinel node occupied by dendritic cells (total and mature)

Secondary Outcome Measures :
  1. Time to maximal dendritic cell infiltration into the dermis

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912574


Locations
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United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Craig L Slingluff, MD University of Virginia
More Information
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Responsible Party: Craig L Slingluff MD, University of Virginia
ClinicalTrials.gov Identifier: NCT00912574    
Other Study ID Numbers: 8380
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009
Keywords provided by University of Virginia:
Melanoma
adjuvant
dendritic cells
vaccine
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Molgramostim
Sargramostim
Monatide (IMS 3015)
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic