Velcade Plus ICE for Patients With Relapsed Classical Hodgkin Lymphoma
- To determine the toxicity profile of multiple doses of bortezomib when given with ICE in patients with relapsed and refractory classical Hodgkin lymphoma (HL).
- To determine the maximum tolerated dose (MTD) of bortezomib when given in combination with ICE chemotherapy in patients with relapsed and refractory classical Hodgkin lymphoma (HL).
- To determine the overall response rate and complete response rate in patients with relapsed and refractory classical Hodgkin lymphoma (HL).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase-I Study of Bortezomib (VELCADE) Plus ICE (Ifosfamide, Carboplatin, Etoposide) for Patients With Relapsed Classical Hodgkin Lymphoma|
- Maximum Tolerable Dose (MTD) of Bortezomib when given in combination with ICE chemotherapy in participants with relapsed and refractory classical Hodgkin lymphoma (HL) [ Time Frame: Two-week cycle ] [ Designated as safety issue: Yes ]MTD dose escalation stops either at the highest indicated dose of bortezomib (1.5 mg/m2), or when a Dose limiting toxicity (DLT) has been observed in at least one third of the patients at any dose level.
|Study Start Date:||February 2007|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Bortezomib + ICE
Bortezomib + ICE (Ifosfamide, Carboplatin, Etoposide):
Bortezomib 1.0 mg/m^2 intravenous (IV) over 5 Seconds on Days 1 and 4; + ICE (Ifosfamide 5 Gm/m^2 IV continuous infusion on Day 1, Carboplatin 5 AUC IV over 1 Hour Day 1, Etoposide 100 mg/m^2 IV over 2 Hours Days 1-3) + Mesna 5 mg/m^2 IV continuous infusion Day 1; 2 Gm/m^2 IV continuous infusion over 12 Hours.
1.0 mg/m^2 by Vein Over 5 Seconds on Days 1 and 4
Other Names:Drug: Carboplatin
5 AUC by Vein Over 1 Hour On Day 1
Other Name: Paraplatin®Drug: Etoposide
100 mg/m^2 By Vein Over 2 Hours On Days 1-3
Other Name: VePesid®Drug: Ifosfamide
5 Gm/m^2 By Vein Continuous Infusion Over 24 Hours On Day 1Drug: Mesna
5 mg/m^2 IV continuous Infusion over 24 Hours On Day 1; 2 Gm/m^2 IV continuous infusion over 12 hours starting after completion of Ifosfamide + Mesna 24 hour continuous infusion
Other Name: Mesnex
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439361
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michelle A. Fanale, MD||M.D. Anderson Cancer Center|