Clinical trial · Interventional
Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery
Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed unresectable stage IV melanoma * Measurable metastatic disease * No uncontrolled brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * More than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT and SGPT no greater than 3 times ULN * Alkaline phosphatase no greater than 3 times ULN Renal: * BUN no greater than 1.5 times ULN * Creatinine no greater than 1.5 times ULN Cardiovascular: * No significant cardiovascular disease Other: * No non-malignant systemic disease * No acute infection requiring IV antibiotics * No alcohol or substance abuse * No other condition, disease, or history of other illness that would preclude study participation * No hypersensitivity, allergic reactions, or intolerance to study drugs * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * No prior interleukin-2 * No other concurrent immunotherapy * No concurrent investigational vaccines or immunomodulatory agents * No other concurrent growth factors Chemotherapy: * At least 4 weeks since prior chemotherapy * No prior temozolomide * No other concurrent anticancer chemotherapy Endocrine therapy: * No concurrent steroids (including corticosteroids) Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics * At least 3 weeks since prior major surgery Other: * At least 30 days since prior immune-based therapy * No concurrent participation in other clinical trials with investigational drugs * No other concurrent anticancer drugs * No concurrent immunosuppressive therapy * No concurrent levamisole or cimetidine
References
Publications (1)
- RESULTWeber RW, O'Day S, Rose M, Deck R, Ames P, Good J, Meyer J, Allen R, Trautvetter S, Timmerman M, Cruickshank S, Cook M, Gonzalez R, Spitler LE. Low-dose outpatient chemobiotherapy with temozolomide, granulocyte-macrophage colony stimulating factor, interferon-alpha2b, and recombinant interleukin-2 for the treatment of metastatic melanoma. J Clin Oncol. 2005 Dec 10;23(35):8992-9000. doi: 10.1200/JCO.2005.02.5791. Epub 2005 Oct 31. PMID 16260693