Clinical trial · Interventional
Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma
Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma
NCT00616564CI-TRIAL-00006837completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998. Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions discussed above.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary Objective
- timeFrame
- one - two years
- description
- Determine the 1 and 2-year survival of patients treated according to protocol. Assess the safety and toxicity of this regimen in this patient population
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of melanoma with measurable disease * Patients with stage IV or unresectable advanced melanoma * Age at least 16 years. * ECOG performance status of 0-1 * Life expectancy \> 3 months * Adequate major organ function to tolerate therapy, as defined by: * Total bilirubin 2.0 mg/dL. * Creatinine 1.8 mg/dL. * WBC 3,000/mm3. * Platelet count 100,000/mm3. * Patients 50 years of age with one or more cardiac risk factors must demonstrate normal exercise stress test, stress thallium test, or comparable cardiac ischemia evaluation * Left ventricular ejection fraction \> 40% * Women of childbearing age must agree to use barrier method birth control and demonstrate a negative pregnancy test prior to initiation of protocol therapy. Periodic negative urine pregnancy tests will also be required. * Patients must give written informed consent Exclusion Criteria: * No prior HD- IL-2 for stage IV/unresectable advanced disease. Prior low dose IL-2 is allowed. * No more than 2 prior chemotherapy regimens are allowed. * No active CNS metastases. Treated CNS metastases without recurrence or progression for \> 8 weeks are allowed. * No concurrent use of systemic corticosteroids * Pregnant and/or lactating are excluded * No concurrent antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccines, or other experimental therapies. * No treatment for melanoma within the previous 4 weeks.
References
Publications (0)
Data not yet available
No reference posted for this study.