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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)

Primary Purpose

Melanoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GM-CSF-in-adjuvant
Montanide ISA-51
GM-CSF and Montanide ISA-51
Saline
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, adjuvant, dendritic cells, vaccine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Saline

GM-CSF

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

Arm Description

first of 4 arms: injection: 1 ml saline

Second of 4 arms: injection: specified dose of GM-CSF in 1 ml saline

Third of 4 arms: injection: 0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline

Fourth of 4 arms: injection: specified dose of GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant

Outcomes

Primary Outcome Measures

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

Time to maximal dendritic cell infiltration into the dermis

Full Information

First Posted
June 1, 2009
Last Updated
June 2, 2009
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT00912574
Brief Title
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
Acronym
MEL38
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 Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 ml saline GM-CSF in 1 ml saline an emulsion of Montanide ISA-51 adjuvant and saline 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, adjuvant, dendritic cells, vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Active Comparator
Arm Description
first of 4 arms: injection: 1 ml saline
Arm Title
GM-CSF
Arm Type
Active Comparator
Arm Description
Second of 4 arms: injection: specified dose of GM-CSF in 1 ml saline
Arm Title
0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline
Arm Type
Active Comparator
Arm Description
Third of 4 arms: injection: 0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline
Arm Title
GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant
Arm Type
Active Comparator
Arm Description
Fourth of 4 arms: injection: specified dose of GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant
Intervention Type
Drug
Intervention Name(s)
GM-CSF-in-adjuvant
Intervention Description
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 ml saline specified dose of GM-CSF in 1 ml saline an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
Intervention Type
Drug
Intervention Name(s)
Montanide ISA-51
Intervention Description
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 ml saline specified dose of GM-CSF in 1 ml saline an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
Intervention Type
Biological
Intervention Name(s)
GM-CSF and Montanide ISA-51
Intervention Description
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 ml saline specified dose of GM-CSF in 1 ml saline an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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 ml saline specified dose of GM-CSF in 1 ml saline an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
Primary Outcome Measure Information:
Title
Number of dendritic cells (total and mature) accumulating in the dermis after administration of the adjuvant
Title
Proportion of the sentinel node occupied by dendritic cells (total and mature)
Secondary Outcome Measure Information:
Title
Time to maximal dendritic cell infiltration into the dermis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig L Slingluff, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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