Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs. Biochemotherapy Using Cisplatin + Vinblastine + DTIC + Interferon Plus IL-2
Sponsor study identifier
Secondary identifiers
NIH
OTHER · UT MD Anderson Cancer Center
OTHER · UT MD Anderson Cancer Center
REGISTRY · NCI PDQ
interventional
140
1 country
1
Study Start
November 1995
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2003
Actual (reported)Study Completion
April 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1995
Date type not reportedThis date has not been verified as actual or estimated.
November 1, 1999
Actual (reported)January 27, 2003
Actual (reported)August 2003
Actual (reported)April 2006
Actual (reported)Effectiveness of Interferon Alfa with/without Combination Chemotherapy + Interleukin-2 for Melanoma
1 year
Schedule A: IV Interferon alfa-2b (IFN-A) induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.
Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks.
Cisplatin IV Days 1-4; Vinblastine IVPB Days 1-4; Dacarbazine (DTIC) IVPB on Day 1; IFN-A is given subcutaneously on days 1-5; IL-2 continuous infusion for 96 hours on Days 1-4. Each course repeated every 21 days for 4 courses.
Infusion for a total of 96 hours on days 1-4
IFN-A Therapy Groups: Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks. Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
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.
Agop Y. Bedikian, MD
M.D. Anderson Cancer Center
140 participants (actual enrollment reported by the registry).
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
November 1995
Date type not reportedThis date has not been verified as actual or estimated.
Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma
IV Days 1-4
IVPB on day 1
IVPB on days 1-4
Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.
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Primary Completion
August 2003
Actual (reported)Study Completion
April 2006
Actual (reported)Last Updated
December 13, 2011
Record last verified: 2011-12
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Source: ClinicalTrials.gov.
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