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

NCT00912574 | Completed

• 1 other identifier: 8380
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

Melanoma; adjuvant; dendritic cells; vaccine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Time to maximal dendritic cell infiltration into the dermis

Study Arms (4)

Saline

ACTIVE COMPARATOR

first of 4 arms: injection: 1 ml saline

Drug: Saline

GM-CSF

ACTIVE COMPARATOR

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

Drug: GM-CSF-in-adjuvant

0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline

ACTIVE COMPARATOR

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

Drug: Montanide ISA-51

GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant

ACTIVE COMPARATOR

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

Interventions

GM-CSF-in-adjuvant DRUG

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

GM-CSF

Montanide ISA-51 DRUG

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

0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline

GM-CSF and Montanide ISA-51 BIOLOGICAL

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

GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant

Saline DRUG

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

Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

montanide ISA 51; Granulocyte-Macrophage Colony-Stimulating Factor; Sodium Chloride

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Craig L Slingluff, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: June 1, 2004
• Primary Completion: July 1, 2008
• Last Updated: June 3, 2009

Record last verified: 2009-06

Locations

US (1)