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)

June 2, 2009 updated by: University of Virginia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Time to maximal dendritic cell infiltration into the dermis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Craig L Slingluff, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

June 3, 2009

Last Update Submitted That Met QC Criteria

June 2, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8380

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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