Clinical trial · Interventional
Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
A Phase II Study of Maintenance Biotherapy With Interleukin-2 and Granulocyte-Macrophage Colony Stimulating Factor in Patients With Metastatic Melanoma With a Partial Response or Stable Disease After Systemic Therapy
- 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)
RATIONALE: Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: This phase II trial is studying how well giving interleukin-2 together with sargramostim works in treating patients with stage III or stage IV melanoma that was previously treated with chemotherapy.
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 |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| aldesleukin | Biological | Aldesleukin | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed melanoma
* Stage III or IV disease
* No primary ocular melanoma
* Stable disease (SD) or partial response (PR) after prior systemic chemotherapy completed at least 4 weeks ago
* Patients whose second post-chemotherapy evaluation (performed at least 4 weeks after the first evaluation that demonstrated SD or PR AND within 2 weeks before study entry) of disease demonstrates continued tumor shrinkage are not eligible
* Patients whose second evaluation shows disease progression are eligible unless one of the following is true:
* Lactic dehydrogenase (LDH) ≥ 2 times upper limit of normal (ULN)
* LDH \> ULN AND is higher than the patient's highest value before systemic chemotherapy
* Patient has developed a new tumor measuring \> 1 cm in diameter
* Sum of the longest diameters of the existing tumor has increased \> 20%
* Evaluable or measurable disease
* Not potentially curable by surgery
* No active CNS metastases
* Solitary brain metastasis allowed if completely resected or completely ablated with radiosurgery more than 1 month before study entry
PATIENT CHARACTERISTICS:
Age
* 16 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No active bleeding
Hepatic
* See Disease Characteristics
* Bilirubin ≤ 2.0 mg/dL
Renal
* Creatinine ≤ 1.2 mg/dL
Cardiovascular
* Patients ≥ 50 years of age OR those with one or more cardiac risk factors must demonstrate one of the following:
* Normal exercise stress test
* Normal stress thallium test
* Normal comparable cardiac ischemia evaluation
* LVEF ≥ 40%
Other
* No active infection requiring treatment
* No concurrent medical or psychiatric condition that would increase the potential toxicity of study treatment
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No other concurrent antineoplastic biologic response modifier therapy
* No concurrent antineoplastic vaccine therapy
Chemotherapy
* See Disease Characteristics
* No concurrent antineoplastic chemotherapy
Endocrine therapy
* No concurrent steroidal antiemetics
* No concurrent systemic corticosteroids
Radiotherapy
* See Disease Characteristics
* No concurrent antineoplastic radiotherapy
Surgery
* See Disease Characteristics
* Recovered from prior surgery
* Surgery within the past 4 weeks allowed provided there is no evidence of disease progression
Other
* More than 4 weeks since prior therapy for melanoma
* No other concurrent antineoplastic experimental therapyReferences
Publications (0)
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