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Trial record 8 of 8 for:    "Enteropathy-Associated T-Cell Lymphoma" | "Antineoplastic Agents, Phytogenic"

SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00787527
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Drug: Zolinza (vorinostat)
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Enrollment 14
Recruitment Details Recruitment Period: 04/03/09 to 12/19/12. All participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Zolinza + CHOP
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Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)

Doxorubicin: 50 mg/m^2 by vein/intravenous (IV) over 15 minutes on Day 1 of 21 day cycle

Prednisone: 100 mg tablets by mouth/orally (PO) once a day on Days 1-5 of 21 day cycle

Zolinza (vorinostat): Phase I Starting dose of 300 mg by mouth each evening on Days 5-14 of 21 day cycle.

Cyclophosphamide: 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle

Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle

Period Title: Overall Study
Started 14
Completed 11
Not Completed 3
Reason Not Completed
Toxicity             3
Arm/Group Title Zolinza + CHOP
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Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)

Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle

Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle

Zolinza (vorinostat) : Starting oral dose (Schedule A) of 300 mg once a day on Days 5-14 of 21 day cycle.

Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle

Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants
55
(29 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
6
  42.9%
Male
8
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
Vorinostat Treatment (Schedule A/Schedule B)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
300 mg once daily on Days 5 to14 6
200 mg twice daily on Days 5 to14 2
300 mg three times daily on Days -2 to 3 6
[1]
Measure Description: Number of participants who received either Vorinostat treatment Schedule A (300 mg once daily or 200 mg twice daily) for Phase I or Schedule B (300 mg three times daily) for Phase II.
1.Primary Outcome
Title Phase I Maximum Tolerated Dose (MTD) of Vorinostat
Hide Description MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); and for Phase II Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).
Time Frame 21 Days
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[Not Specified]
Arm/Group Title Schedule A - Vorinostat Once or Twice Daily
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Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle or Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle

Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)

Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle

Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle

Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle

Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: mg/day
300
2.Primary Outcome
Title Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat
Hide Description MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD.
Time Frame 21 Days
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Schedule A - Vorinostat Once Daily Schedule A - Vorinostat Twice Daily
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Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle

Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)

Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle

Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle

Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle

Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle

Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle

Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)

Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle

Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle

Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle

Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle

Overall Number of Participants Analyzed 6 2
Measure Type: Number
Unit of Measure: participants
1 2
3.Primary Outcome
Title Phase II MTD of Vorinostat
Hide Description MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).
Time Frame 21 Days
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Schedule B - Vorinostat Three Times Daily
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Vorinostat administered orally 300 mg three times daily from days -2 to 3 (4500 mg over 5 days per cycle) of 21 day cycle.

Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)

Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle

Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle

Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle

Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: mg/three times daily
300
Time Frame Adverse event reporting period begins once study drug treatment is initiated through 30 days after the last study treatment (21 day cycle). Overall study participation July 2009 to August 2012 for Phase I (Schedule A) and Phase II (Schedule B).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Schedule A: Vorinostat Once or Twice Daily Schedule B: Vorinostat Three Times Daily
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Phase I: Vorinostat administered Days 5 to 14 at starting dose 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), next administered dose 200 mg orally twice daily (4000 mg over 10 days per cycle).

Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m^2 IV Day 1; Vincristine 1.4 mg/m^2 IV Day 1.

Phase II: Vorinostat administered at starting dose 300 mg orally three times daily from Days -2 to 3 (4500 mg over 5 days per cycle).

Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m^2 IV Day 1; Vincristine 1.4 mg/m^2 IV Day 1.

All-Cause Mortality
Schedule A: Vorinostat Once or Twice Daily Schedule B: Vorinostat Three Times Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Schedule A: Vorinostat Once or Twice Daily Schedule B: Vorinostat Three Times Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      5/6 (83.33%)    
Blood and lymphatic system disorders     
Thrombocytopenia  1  2/8 (25.00%)  2 0/6 (0.00%)  0
Neutropenia  1  5/8 (62.50%)  5 3/6 (50.00%)  3
Thrombosis  1  1/8 (12.50%)  1 0/6 (0.00%)  0
Anaemia  1  0/8 (0.00%)  0 1/6 (16.67%)  1
Gastrointestinal disorders     
Vomiting  1  1/8 (12.50%)  1 0/6 (0.00%)  0
Constipation  1  1/8 (12.50%)  1 0/6 (0.00%)  0
Diarrhoea  1  0/8 (0.00%)  0 1/6 (16.67%)  1
General disorders     
Oral Mucositis  1  1/8 (12.50%)  1 0/6 (0.00%)  0
Dehydration  1  1/8 (12.50%)  1 0/6 (0.00%)  0
Pain  1  2/8 (25.00%)  2 0/6 (0.00%)  0
Infections and infestations     
Neutropenic fever  1  1/8 (12.50%)  1 0/6 (0.00%)  0
Metabolism and nutrition disorders     
Hyponatraemia  1  1/8 (12.50%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/8 (12.50%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Schedule A: Vorinostat Once or Twice Daily Schedule B: Vorinostat Three Times Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders     
Thrombocytopenia  1  1/8 (12.50%)  1 2/6 (33.33%)  2
Neutropenia  1  0/8 (0.00%)  0 2/6 (33.33%)  2
Thrombosis  1  0/8 (0.00%)  0 2/6 (33.33%)  2
Anaemia  1  0/8 (0.00%)  0 4/6 (66.67%)  4
Cardiac disorders     
Oedema  1  3/8 (37.50%)  3 0/6 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea  1  5/8 (62.50%)  5 2/6 (33.33%)  2
Nausea  1  5/8 (62.50%)  5 2/6 (33.33%)  2
Vomiting  1  3/8 (37.50%)  3 3/6 (50.00%)  3
Constipation  1  1/8 (12.50%)  1 3/6 (50.00%)  3
General disorders     
Fatigue * 1  6/8 (75.00%)  6 5/6 (83.33%)  5
Oral Mucositis  1  2/8 (25.00%)  2 0/6 (0.00%)  0
Insomnia  1  1/8 (12.50%)  1 0/6 (0.00%)  0
Dizziness  1  4/8 (50.00%)  4 0/6 (0.00%)  0
Anorexia  1  0/8 (0.00%)  2/6 (33.33%)  2
Pain  1  3/8 (37.50%)  3 0/6 (0.00%)  0
Infections and infestations     
Other infection  1  2/8 (25.00%)  2 2/6 (33.33%)  2
Metabolism and nutrition disorders     
Hyperuricaemia  1  1/8 (12.50%)  1 1/6 (16.67%)  1
Nervous system disorders     
Memory impairment  1  2/8 (25.00%)  2 0/6 (0.00%)  0
Sensory neuropathy  1  3/8 (37.50%)  3 0/6 (0.00%)  0
Psychiatric disorders     
Depression  1  1/8 (12.50%)  1 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/8 (0.00%)  0 2/6 (33.33%)  2
Dyspnea  1  3/8 (37.50%)  3 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  1  1/8 (12.50%)  1 1/6 (16.67%)  1
Pruritus  1  1/8 (12.50%)  1 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yasuhiro Oki, MD/ Associate Professor
Organization: University of Texas MD Anderson Cancer Center
Phone: 713-792-2860
EMail: yoki@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00787527     History of Changes
Other Study ID Numbers: 2008-0484
First Submitted: November 6, 2008
First Posted: November 7, 2008
Results First Submitted: September 2, 2014
Results First Posted: September 9, 2014
Last Update Posted: September 9, 2014