Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma

Phase 3 Completed 140 enrolled M.D. Anderson Cancer Center National Cancer Institute (NCI) · collab

RandomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa plus combination chemotherapy and interleukin-2 is more effective than interferon alfa alone in treating patients with melanoma. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma.

Timeline

Start: 1995-11
Primary completion: 2003-08
Completion: 2006-04

Outcome

Missed primary endpoint

paper there were no significant differences in estimated median RFS or OS (P=0.86 and 0.45, respectively) between the two groups. PMID 19430405 ↗

Publications

Results Kim KB, Legha SS, Gonzalez R, Anderson CM, Johnson MM, Liu P, Papadopoulos NE, Eton O, Plager C, Buzaid AC, Prieto VG, Hwu WJ, Frost AM, Alvarado G, Hwu P, Ross MI, Gershenwald JE, Lee JE, Mansfield PF, Benjamin RS, Bedikian AY. A randomized phase III trial of biochemotherapy versus interferon-alpha-2b for adjuvant therapy in patients at high risk for melanoma recurrence. Melanoma Res. 2009 Feb;19(1):42-9. doi: 10.1097/CMR.0b013e328314b84a.

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	—	—
Subject	recombinant interferon alfa	Protein / enzyme biologic	—	Intravenous