Randomized Phase III Trial to Compare the Immunodulatory Effects of Leukine vs. Saline for Early-stage Melanoma Patients Undergoing Sentinel Lymph Node Dissection
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Stage IB Melanoma
- Sponsor
- Jonsson Comprehensive Cancer Center
- Locations
- 1
- Primary Endpoint
- Reversal of alterations in the SN
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
This randomized phase III trial studies sargramostim before sentinel lymph node biopsy to see how well it works compared to hypertonic saline before sentinel lymph node biopsy in treating patients with melanoma. Biological therapies, such as sargramostim, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether sargramostim is more effective than hypertonic saline in treating patients with stage IB-II melanoma undergoing sentinel lymph node biopsy.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Reversal of alterations in the SN
Time Frame: Up to 30 days
A series of analysis of variance (ANOVA) models will be employed.
Proportion of subjects with positive SN in each group
Time Frame: Up to 30 days
The primary analysis will be a two group continuity corrected Chi-squared test. A logistic regression analysis will also be run.
Secondary Outcomes
- Overall survival (OS)(Up to 30 days)
- Disease free survival (DFS)(Up to 30 days)