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
  Purpose

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 Intervention
Melanoma
Drug: GM-CSF-in-adjuvant
Drug: Montanide ISA-51
Biological: GM-CSF and Montanide ISA-51
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Time to maximal dendritic cell infiltration into the dermis [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: June 2004
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912574

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Craig L Slingluff, MD University of Virginia
  More Information

No publications provided

Responsible Party: Craig L Slingluff MD, University of Virginia
ClinicalTrials.gov Identifier: NCT00912574     History of Changes
Other Study ID Numbers: 8380
Study First Received: June 1, 2009
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
Melanoma
adjuvant
dendritic cells
vaccine

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014