Trial Outcomes & Findings for 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 (NCT NCT00601718)
NCT ID: NCT00601718
Last Updated: 2017-05-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
28 days post last dose of study drug
Results posted on
2017-05-25
Participant Flow
Participant milestones
| Measure |
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
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 Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
n=29 Participants
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
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days post last dose of study drugOutcome measures
| Measure |
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
n=29 Participants
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
|
|---|---|
|
Maximum Tolerated Dose of Vorinostat
|
500 mg twice daily X 5 days
|
PRIMARY outcome
Timeframe: 3-5 weeks post end of treatmentCommon dose limiting toxicities.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
n=29 Participants
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
|
|---|---|
|
Safety and Toxicity According to CTCAE v3.0
Hypokalemia
|
2 Participants
|
|
Safety and Toxicity According to CTCAE v3.0
Transaminitis
|
2 Participants
|
|
Safety and Toxicity According to CTCAE v3.0
Grade 3 related gastrointestinal toxicity
|
9 Participants
|
|
Safety and Toxicity According to CTCAE v3.0
Infection
|
2 Participants
|
PRIMARY outcome
Timeframe: 3-5 weeks post end of treatmentOutcome measures
| Measure |
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
n=29 Participants
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
|
|---|---|
|
Efficacy (Response Rate) of Vorinostat Combined With RICE Chemotherapy
|
19 Participants
|
PRIMARY outcome
Timeframe: 1-3 weeks post end of treatmentOutcome measures
| Measure |
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
n=21 Participants
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
|
|---|---|
|
Ability to Proceed to Peripheral Blood Stem Cell Collection Following Treatment
|
20 Participants
|
Adverse Events
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
Serious events: 10 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
n=29 participants at risk
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
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.4%
1/29
|
|
Nervous system disorders
Encephalopathy
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.3%
3/29
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
3.4%
1/29
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29
|
|
Vascular disorders
Hypotension
|
3.4%
1/29
|
|
Immune system disorders
Allergic reaction
|
3.4%
1/29
|
|
Nervous system disorders
Syncope
|
3.4%
1/29
|
Other adverse events
| Measure |
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
n=29 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
27.6%
8/29
|
|
Infections and infestations
Infection
|
27.6%
8/29
|
|
Gastrointestinal disorders
Nausea
|
20.7%
6/29
|
|
Metabolism and nutrition disorders
Dehydration
|
17.2%
5/29
|
|
Metabolism and nutrition disorders
Anorexia
|
10.3%
3/29
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
2/29
|
|
Metabolism and nutrition disorders
Hypophasphataemia
|
41.4%
12/29
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
34.5%
10/29
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.8%
4/29
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
13.8%
4/29
|
|
Investigations
AST/ALT
|
13.8%
4/29
|
|
General disorders
DVT
|
6.9%
2/29
|
|
General disorders
Elevated PTT
|
10.3%
3/29
|
|
General disorders
Pain
|
13.8%
4/29
|
|
General disorders
Fatigue
|
10.3%
3/29
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.9%
2/29
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place