Phase I Study of Romidepsin Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
The goal of this clinical research study is find the highest tolerable dose of romidepsin that can be given in combination with ifosfamide, carboplatin, etoposide (ICE) to patients with PTCL. The safety of this drug combination will also be studied.
Romidepsin is designed to stop the growth of cancer cells and block new blood vessels from forming around the cancer cells. This may cause the cancer cells to die.
Ifosfamide and etoposide are designed to slow or stop the growth of cancer cells.
Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Romidepsin (ISTODAX®) Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma|
- Maximum Tolerated Dose (MTD) of Romidepsin Plus ICE [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]Maximum tolerated dose (MTD) is dose at which 20% of patients experience a dose limiting toxicity (DLT). DLT defined as drug-related adverse event with attribution of possible, probable, or definite and fulfilling one of following criteria. DLT assessment during cycle 1 of therapy. Adverse event grade 3 or 4 non-hematologic toxicity attributed to romidepsin that cannot be controlled or prevented by supportive care. Grade 4 thrombocytopenia or neutropenia that lasts for more than 14 days.
- Overall Response Rate (ORR) of Romidepsin Plus ICE [ Time Frame: 14 days after the last dose of study drug ] [ Designated as safety issue: No ]
Response classified per these criteria as complete response (CR), partial remission (PR), stable disease (SD), and progressive disease (PD).
Standard response criteria from the revised lymphoma response criteria used to assess response.
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Experimental: Romidepsin + ICE
Starting dose of Romidepsin: 8 mg/m2 by vein on Days 1 and 4 of a 14 Day cycle.
Ifosfamide plus Mesna: 5 gm/m2 for both given by vein over 24 hours on Day 1 of a 14 Day cycle.
Mesna: 2 gm/m2 given by vein given over 12 hours on Day 1 of a 14 Day cycle. Starts after completion of Ifosfamide plus Mesna administration.
Carboplatin: mg to equal target area under curve (AUC) by Calvert equation of 5 mg/ml/min with a maximum of 750 mg, given by vein over 1 hour on Day 1 of a 14 Day cycle.
Etoposide: 100 mg/m2 given by vein over 2 hours on Days 1 - 3 of a 14 Day cycle.
Starting Dose: 8 mg/m2 by vein on Days 1 and 4 of a 14 Day cycle.
Other Names:Drug: Ifosfamide
5 gm/m2 by vein on Day 1 of a 14 Day cycle.
Other Name: IfexDrug: Mesna
5 gm/m2 by vein given with Ifosfamide over 24 hours on Day 1 of a 14 Day cycle.
2 gm/m2 by vein given over 12 hours starting after completion of ifosfamide plus MESNA on Day 1 of a 14 Day cycle.
Other Name: MesnexDrug: Carboplatin
mg to equal target area under curve (AUC) by Calvert equation of 5 mg/ml/min with a maximum of 750 mg by vein on Day 1 of a 14 Day cycle.
Other Name: ParaplatinDrug: Etoposide
100 mg/m2 by vein on Days 1 - 3 of a 14 Day cycle.
Other Name: VePesid
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01590732
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michelle A. Fanale, MD||M.D. Anderson Cancer Center|