Velcade Plus ICE for Patients With Relapsed Classical Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT00439361|
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : July 9, 2012
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma Lymphoma||Drug: Bortezomib Drug: Carboplatin Drug: Etoposide Drug: Ifosfamide Drug: Mesna||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase-I Study of Bortezomib (VELCADE) Plus ICE (Ifosfamide, Carboplatin, Etoposide) for Patients With Relapsed Classical Hodgkin Lymphoma|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
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
5 AUC by Vein Over 1 Hour On Day 1
Other Name: Paraplatin®
100 mg/m^2 By Vein Over 2 Hours On Days 1-3
Other Name: VePesid®
5 Gm/m^2 By Vein Continuous Infusion Over 24 Hours On Day 1
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
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|