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Evaluation of the Effects of Local GM-CSF-in-Adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes


N/A
18 Years
85 Years
Not Enrolling
Both
Melanoma

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Trial Information

Evaluation of the Effects of Local GM-CSF-in-Adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of dendritic cells (total and mature) accumulating in the dermis after administration of the adjuvant

Safety Issue:

Yes

Principal Investigator

Craig L Slingluff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Food and Drug Administration

Study ID:

8380

NCT ID:

NCT00912574

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Melanoma
  • Melanoma
  • adjuvant
  • dendritic cells
  • vaccine
  • Melanoma

Name

Location

University of VirginiaCharlottesville, Virginia  22908