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Trial record 22 of 23 for:    CD20 Fred Hutchinson

Vorinostat, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Lymphoma or Previously Untreated T-Cell Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00601718
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ajay Gopal, University of Washington

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Contiguous Stage II Mantle Cell Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma
Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
Stage I Mantle Cell Lymphoma
Stage I Mycosis Fungoides/Sezary Syndrome
Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
Stage II Mycosis Fungoides/Sezary Syndrome
Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
Stage III Mantle Cell Lymphoma
Stage III Mycosis Fungoides/Sezary Syndrome
Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
Stage IV Mantle Cell Lymphoma
Stage IV Mycosis Fungoides/Sezary Syndrome
Waldenström Macroglobulinemia
Interventions Drug: vorinostat
Biological: rituximab
Drug: ifosfamide
Drug: carboplatin
Drug: etoposide
Other: pharmacological study
Other: laboratory biomarker analysis
Genetic: gene expression analysis
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
Hide Arm/Group Description

Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

vorinostat: Given PO

rituximab: Given IV

ifosfamide: Given IV

carboplatin: Given IV

etoposide: Given IV

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

gene expression analysis: Correlative studies

Period Title: Overall Study
Started 29
Completed 29
Not Completed 0
Arm/Group Title Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
Hide Arm/Group Description

Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

vorinostat: Given PO

rituximab: Given IV

ifosfamide: Given IV

carboplatin: Given IV

etoposide: Given IV

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

gene expression analysis: Correlative studies

Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants
56
(23 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
7
  24.1%
Male
22
  75.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
27
  93.1%
Unknown or Not Reported
2
   6.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
American Indian or Alaska Native
1
   3.4%
Asian
1
   3.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
27
  93.1%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Maximum Tolerated Dose of Vorinostat
Hide Description [Not Specified]
Time Frame 28 days post last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
Hide Arm/Group Description:

Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

vorinostat: Given PO

rituximab: Given IV

ifosfamide: Given IV

carboplatin: Given IV

etoposide: Given IV

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

gene expression analysis: Correlative studies

Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: mg twice daily X 5 days
500
2.Primary Outcome
Title Safety and Toxicity According to CTCAE v3.0
Hide Description Common dose limiting toxicities.
Time Frame 3-5 weeks post end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
Hide Arm/Group Description:

Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

vorinostat: Given PO

rituximab: Given IV

ifosfamide: Given IV

carboplatin: Given IV

etoposide: Given IV

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

gene expression analysis: Correlative studies

Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
Infection
2
   6.9%
Hypokalemia
2
   6.9%
Transaminitis
2
   6.9%
Grade 3 related gastrointestinal toxicity
9
  31.0%
3.Primary Outcome
Title Efficacy (Response Rate) of Vorinostat Combined With RICE Chemotherapy
Hide Description [Not Specified]
Time Frame 3-5 weeks post end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
Hide Arm/Group Description:

Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

vorinostat: Given PO

rituximab: Given IV

ifosfamide: Given IV

carboplatin: Given IV

etoposide: Given IV

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

gene expression analysis: Correlative studies

Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
19
  65.5%
4.Primary Outcome
Title Ability to Proceed to Peripheral Blood Stem Cell Collection Following Treatment
Hide Description [Not Specified]
Time Frame 1-3 weeks post end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
Hide Arm/Group Description:

Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

vorinostat: Given PO

rituximab: Given IV

ifosfamide: Given IV

carboplatin: Given IV

etoposide: Given IV

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

gene expression analysis: Correlative studies

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
20
  95.2%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
Hide Arm/Group Description

Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

vorinostat: Given PO

rituximab: Given IV

ifosfamide: Given IV

carboplatin: Given IV

etoposide: Given IV

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

gene expression analysis: Correlative studies

All-Cause Mortality
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
Affected / at Risk (%)
Total   10/29 (34.48%) 
Blood and lymphatic system disorders   
Febrile neutropenia  3/29 (10.34%) 
Gastrointestinal disorders   
Nausea/Vomiting  1/29 (3.45%) 
Diarrhea  1/29 (3.45%) 
Immune system disorders   
Allergic reaction  1/29 (3.45%) 
Nervous system disorders   
Encephalopathy  1/29 (3.45%) 
Syncope  1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1/29 (3.45%) 
Vascular disorders   
Hypotension  1/29 (3.45%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
Affected / at Risk (%)
Total   25/29 (86.21%) 
Blood and lymphatic system disorders   
Febrile neutropenia  8/29 (27.59%) 
Gastrointestinal disorders   
Nausea  6/29 (20.69%) 
Vomiting  2/29 (6.90%) 
General disorders   
DVT  2/29 (6.90%) 
Elevated PTT  3/29 (10.34%) 
Pain  4/29 (13.79%) 
Fatigue  3/29 (10.34%) 
Infections and infestations   
Infection  8/29 (27.59%) 
Investigations   
AST/ALT  4/29 (13.79%) 
Metabolism and nutrition disorders   
Dehydration  5/29 (17.24%) 
Anorexia  3/29 (10.34%) 
Hypophasphataemia  12/29 (41.38%) 
Hypokalaemia  10/29 (34.48%) 
Hyponatraemia  4/29 (13.79%) 
Hypercalcemia  4/29 (13.79%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia  2/29 (6.90%) 
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: Ajay Gopal
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-288-2037
EMail: akgopal@fhcrc.org
Layout table for additonal information
Responsible Party: Ajay Gopal, University of Washington
ClinicalTrials.gov Identifier: NCT00601718     History of Changes
Other Study ID Numbers: PSOC 2302
NCI-2010-00870 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: January 24, 2008
First Posted: January 28, 2008
Results First Submitted: April 17, 2017
Results First Posted: May 25, 2017
Last Update Posted: May 25, 2017