Clinical trial · Interventional
Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma
Randomized Phase III Trial to Compare the Immunodulatory Effects of Leukine vs. Saline for Early-stage Melanoma Patients Undergoing Sentinel Lymph Node Dissection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants enrolled
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypertonic saline | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (sargramostim and sentinel lymph node biopsy)
- description
- Patients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy.
- interventionNames
- Biological: sargramostim
- Procedure: sentinel lymph node biopsy
- Other: laboratory biomarker analysis
- type
- ACTIVE_COMPARATOR
- label
- Arm II (hypertonic saline and sentinel lymph node biopsy)
- description
- Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.
- interventionNames
- Procedure: sentinel lymph node biopsy
- Other: laboratory biomarker analysis
- Other: hypertonic saline
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available