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

NCT ID: NCT00912574

Last Updated: 2009-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30

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. 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.

Conditions

Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Saline

first of 4 arms: injection: 1 ml saline

Group Type: ACTIVE_COMPARATOR

Saline

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

GM-CSF-in-adjuvant

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Montanide ISA-51

Intervention Type: 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 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

Group Type: ACTIVE_COMPARATOR

GM-CSF and Montanide ISA-51

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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

Intervention Type: BIOLOGICAL

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

Intervention Type: DRUG

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

University of Virginia

Principal Investigators

Craig L Slingluff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

8380

Identifier Type: -

Identifier Source: org_study_id