drugset / Trial / NCT00003027
Combination Chemotherapy With or Without Interleukin-2 and Interferon Alfa in Treating Patients With Metastatic Melanoma
Phase 3
Completed
482 enrolled
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B · collabNational Cancer Institute (NCI) · collabSWOG Cancer Research Network · collab
RandomizedTreatment
Summary
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.
Timeline
- Start
- 1997-11-13
- Primary completion
- 2007-07
- Completion
- —
Publications
- Results Atkins 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.
- Results Atkins 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | — | Intravenous |
| Subject | Dacarbazine | Small molecule | — | Intravenous |
| Subject | Vinblastine | Small molecule | — | Intravenous |
| Subject | aldesleukin | Protein / enzyme biologic | — | Intravenous |
| Subject | interferon alfa-2b | Protein / enzyme biologic | — | Subcutaneous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |