Clinical trial · Interventional
Combination Chemotherapy With or Without Interleukin-2 and Interferon Alfa in Treating Patients With Metastatic Melanoma
A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon A-2B Versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients With Metastatic Malignant Melanoma
- 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. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Interferon alfa may interfere with the growth of tumor cells. It is not yet known whether combination chemotherapy plus interleukin-2 and interferon alfa is more effective than combination chemotherapy alone for metastatic melanoma. PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| dacarbazine | Drug | Dacarbazine | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
| vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (3)
- measure
- Response rate (complete and partial response)
- measure
- Durable complete response rate
- measure
- Response duration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed surgically incurable metastatic malignant melanoma * Measurable disease * No active brain metastases or edema * No leptomeningeal disease * No ocular melanoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT less than 3 times the upper limit of normal unless due to liver metastases Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance at least 75 mL/min Cardiovascular: * No congestive heart failure * No symptoms of coronary artery disease * No serious cardiac arrhythmias * No prior myocardial infarction on EKG * Normal cardiac stress test required for the following: * Over 50 years of age * Abnormal EKG * Prior history of cardiac disease Pulmonary: * No symptomatic pulmonary disease * FEV1 greater than 2.0 L OR at least 75% predicted if over 50 years of age or with history of pulmonary symptoms Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No significant infection * HIV negative * No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No organ allografts * No significant disease other than malignancy * No seizure disorder PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior interleukin-2 therapy for metastatic disease * At least 4 weeks since prior vaccine therapy * At least 4 weeks since prior adjuvant immunotherapy Chemotherapy: * No prior chemotherapy for disease Endocrine therapy: * No concurrent corticosteroids Radiotherapy: * No prior radiation therapy to measurable disease site unless disease is clearly progressive * At least 4 weeks since prior radiation therapy for local control or palliation and recovered Surgery: * Recovered from prior surgery Other: * No prior systemic therapy for metastatic disease * At least 3 months since definitive therapy for brain metastases
References
Publications (2)
- RESULTAtkins MB, Hsu J, Lee S, Cohen GI, Flaherty LE, Sosman JA, Sondak VK, Kirkwood JM; Eastern Cooperative Oncology Group. Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): a trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2008 Dec 10;26(35):5748-54. doi: 10.1200/JCO.2008.17.5448. Epub 2008 Nov 10. PMID 19001327
- RESULTAtkins MB, Lee S, Flaherty LE: A prospective randomized phase III trial of concurrent biochemotherapy (BCT) with cisplatin, vinblastine, dacarbazine (CVD), IL-2 and interferon alpha-2b (IFN) versus CVD alone in patients with metastatic melanoma (E3695): an ECOG-coordinated intergroup trial. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2847, 2003.