Trial Outcomes & Findings for Vorinostat in Treating Patients With Relapsed or Refractory Advanced Hodgkin's Lymphoma (NCT NCT00132028)
NCT ID: NCT00132028
Last Updated: 2014-05-23
Results Overview
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
after every 3 cycles on treatment
Results posted on
2014-05-23
Participant Flow
Participant milestones
| Measure |
SAHA (Vorinostat)
Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
Eligible
|
25
|
|
Overall Study
Eligible and Began Protocol Therapy
|
25
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
SAHA (Vorinostat)
Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Death
|
2
|
|
Overall Study
Lack of Efficacy
|
11
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
not eligible
|
2
|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
Vorinostat in Treating Patients With Relapsed or Refractory Advanced Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
SAHA (Vorinostat)
n=25 Participants
Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
|
|---|---|
|
Age, Continuous
|
41.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after every 3 cycles on treatmentPopulation: All patients who started treatment were included in assessing response estimates.
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Outcome measures
| Measure |
SAHA (Vorinostat)
n=25 Participants
Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
|
|---|---|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Unconfirmed Partial Response (UPR)
|
0 participants
|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
No Response
|
24 participants
|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Complete Response (CR)
|
0 participants
|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Partial Response (PR)
|
1 participants
|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Unconfirmed Complete Response (UCR)
|
0 participants
|
SECONDARY outcome
Timeframe: after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.Population: All eligible patients who started treatment were included in assessing progression-free survival.
Measured from date of registration to date of first observation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.
Outcome measures
| Measure |
SAHA (Vorinostat)
n=25 Participants
Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
|
|---|---|
|
Progression-Free Survival
|
4.8 months
Interval 3.4 to 13.2
|
SECONDARY outcome
Timeframe: after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.Population: All eligible patients who started treatment were included in assessing overall survival.
Measured from date of registration to death, or last contact date
Outcome measures
| Measure |
SAHA (Vorinostat)
n=25 Participants
Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
|
|---|---|
|
Overall Survival
|
15.7 months
Interval 6.6 to 34.1
|
Adverse Events
SAHA (Vorinostat)
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SAHA (Vorinostat)
n=25 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
8.0%
2/25 • After every 21-day cycle while on protocol treatment
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • After every 21-day cycle while on protocol treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
|
4.0%
1/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
Creatinine
|
4.0%
1/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
4.0%
1/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
Platelets
|
8.0%
2/25 • After every 21-day cycle while on protocol treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
4.0%
1/25 • After every 21-day cycle while on protocol treatment
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
4.0%
1/25 • After every 21-day cycle while on protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
4.0%
1/25 • After every 21-day cycle while on protocol treatment
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
4.0%
1/25 • After every 21-day cycle while on protocol treatment
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • After every 21-day cycle while on protocol treatment
|
Other adverse events
| Measure |
SAHA (Vorinostat)
n=25 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
80.0%
20/25 • After every 21-day cycle while on protocol treatment
|
|
Gastrointestinal disorders
Constipation
|
12.0%
3/25 • After every 21-day cycle while on protocol treatment
|
|
Gastrointestinal disorders
Diarrhea
|
44.0%
11/25 • After every 21-day cycle while on protocol treatment
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
12.0%
3/25 • After every 21-day cycle while on protocol treatment
|
|
Gastrointestinal disorders
Nausea
|
64.0%
16/25 • After every 21-day cycle while on protocol treatment
|
|
Gastrointestinal disorders
Pain - Stomach
|
8.0%
2/25 • After every 21-day cycle while on protocol treatment
|
|
Gastrointestinal disorders
Vomiting
|
32.0%
8/25 • After every 21-day cycle while on protocol treatment
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
64.0%
16/25 • After every 21-day cycle while on protocol treatment
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
|
16.0%
4/25 • After every 21-day cycle while on protocol treatment
|
|
General disorders
Flu-like syndrome
|
12.0%
3/25 • After every 21-day cycle while on protocol treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
8.0%
2/25 • After every 21-day cycle while on protocol treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
8.0%
2/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
16.0%
4/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
28.0%
7/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
Alkaline phosphatase
|
28.0%
7/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
8.0%
2/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
Creatinine
|
24.0%
6/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
Leukocytes (total WBC)
|
28.0%
7/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
Lymphopenia
|
44.0%
11/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
16.0%
4/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
Platelets
|
44.0%
11/25 • After every 21-day cycle while on protocol treatment
|
|
Investigations
Weight loss
|
20.0%
5/25 • After every 21-day cycle while on protocol treatment
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
16.0%
4/25 • After every 21-day cycle while on protocol treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
10/25 • After every 21-day cycle while on protocol treatment
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
12.0%
3/25 • After every 21-day cycle while on protocol treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
12.0%
3/25 • After every 21-day cycle while on protocol treatment
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
8.0%
2/25 • After every 21-day cycle while on protocol treatment
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
12.0%
3/25 • After every 21-day cycle while on protocol treatment
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
16.0%
4/25 • After every 21-day cycle while on protocol treatment
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
12.0%
3/25 • After every 21-day cycle while on protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
12.0%
3/25 • After every 21-day cycle while on protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
8.0%
2/25 • After every 21-day cycle while on protocol treatment
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • After every 21-day cycle while on protocol treatment
|
|
Nervous system disorders
Neuropathy: sensory
|
12.0%
3/25 • After every 21-day cycle while on protocol treatment
|
|
Nervous system disorders
Pain - Head/headache
|
20.0%
5/25 • After every 21-day cycle while on protocol treatment
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
8.0%
2/25 • After every 21-day cycle while on protocol treatment
|
|
Renal and urinary disorders
Proteinuria
|
12.0%
3/25 • After every 21-day cycle while on protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
16.0%
4/25 • After every 21-day cycle while on protocol treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
2/25 • After every 21-day cycle while on protocol treatment
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
16.0%
4/25 • After every 21-day cycle while on protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.0%
2/25 • After every 21-day cycle while on protocol treatment
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60