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Randomized Phase III Trial to Compare the Immunodulatory Effects of Leukine vs. Saline for Early-stage Melanoma Patients Undergoing Sentinel Lymph Node Dissection


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Stage IB Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma

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Trial Information

Randomized Phase III Trial to Compare the Immunodulatory Effects of Leukine vs. Saline for Early-stage Melanoma Patients Undergoing Sentinel Lymph Node Dissection


PRIMARY OBJECTIVES:

I. To determine if the alterations in morphology and phenotype to the sentinel lymph nodes
are reversible.

II. To determine if the restoration of the morphology or phenotype of sentinel lymph nodes
results in diminished regional tumor burden.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sargramostim subcutaneously (SC) 3-5 days prior to undergoing
sentinel lymph node biopsy.

ARM II: Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph
node biopsy.

After completion of study treatment, patients are followed up for 30 days.


Inclusion Criteria:



- Patients with stage IB or II cutaneous melanoma

- Primaries on the torso, upper and lower extremities and head and neck region

- Skin biopsy performed at least 5 days and no longer than 10 weeks from the time of
initial entry into the study

- Bilirubin < 2.0 ng/dl

- Creatinine < 3.0 ng/dl

- Able to understand the consent competent to sign

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

- Prior wide excision with diameter of the excision > 3 cm

- Primary melanoma arises from the eye or mucus membranes

- Clinical evidence of regional, intransit ,or distant metastases

- Second invasive melanoma

- Prior surgical procedures that would alter the drainage patterns and would prevent us
from identifying sentinel lymph nodes (SN)

- Patients with primary or secondary immunodeficiencies

- Pregnancy

- Known allergy to sargramostim (GM-CSF)

- History of cardiac disease, in particular, supraventricular tachycardia

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reversal of alterations in the SN

Outcome Description:

A series of analysis of variance (ANOVA) models will be employed.

Outcome Time Frame:

Up to 30 days

Safety Issue:

No

Principal Investigator

Richard Essner

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

11-002177

NCT ID:

NCT01826864

Start Date:

August 2011

Completion Date:

Related Keywords:

  • Stage IB Melanoma
  • Stage IIA Melanoma
  • Stage IIB Melanoma
  • Stage IIC Melanoma
  • Melanoma

Name

Location

Jonsson Comprehensive Cancer Center Los Angeles, California  90095