Trial Outcomes & Findings for Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer (NCT NCT00324740)
NCT ID: NCT00324740
Last Updated: 2021-02-23
Results Overview
Defined as the occurrence of one or more of the following toxicities as graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Course 1, up to 28 days
Results posted on
2021-02-23
Participant Flow
A total of 14 patients were enrolled between June 2006 and September 2010
Participant milestones
| Measure |
Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)
Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.25 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
Dose Level 2 Vorinostat (300mg) and Isotretinoin (0.375 mg/kg)
Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.375 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
Dose Level 3: Vorinostat (300mg) and Isotretinoin (0.5 mg/kg)
Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.5 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
4
|
|
Overall Study
COMPLETED
|
6
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)
Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.25 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
Dose Level 2 Vorinostat (300mg) and Isotretinoin (0.375 mg/kg)
Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.375 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
Dose Level 3: Vorinostat (300mg) and Isotretinoin (0.5 mg/kg)
Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.5 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
Baseline Characteristics
Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Vorinostat and Isotretinoin)
n=12 Participants
Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiin or other Pacific Islander
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Course 1, up to 28 daysDefined as the occurrence of one or more of the following toxicities as graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Outcome measures
| Measure |
Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)
n=6 Participants
Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.375 mg/kg)
n=3 Participants
Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.5 mg/kg)
n=3 Participants
Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
|---|---|---|---|
|
Number of Participants With at Least One Dose Limiting Toxicity Associated With Vorinostat Concurrently Administered With Isotretinoin
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Once 2 DLT events occur in patients, the preceding dose will be designated the maximum tolerated dose (MTD).Population: The recommended phase II dose is vorinostat (300 mg bid) + Isotretinoin (0.5 mg/kg PO bid) three days per week
Hematologic: Any Grade 3/4 Thrombocytopenia and/or Grade 3/4 Neutropenia Non-Hematologic: Any \>/= Grade3 non-hematologic toxicity considered by the investigator to be possibly related to study drug and/or any non-hematologic toxicity that results in a dose-delay of more than three weeks.
Outcome measures
| Measure |
Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)
n=12 Participants
Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.375 mg/kg)
Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.5 mg/kg)
Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
|---|---|---|---|
|
Maximum Tolerated Dose of Vorinostat in Combination With Isotretinoin
|
0.5 mg/kg BID
|
—
|
—
|
PRIMARY outcome
Timeframe: Tumor measurements every 8 weeks until disease progressionThe Response Evaluation Criteria in Solid Tumors (RECIST 1.0) was used and tumor responses were defined as complete response (CR), partial response (PR), stable disease (SD) or Progression
Outcome measures
| Measure |
Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)
n=5 Participants
Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.375 mg/kg)
n=3 Participants
Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.5 mg/kg)
n=3 Participants
Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
|---|---|---|---|
|
Objective Response Rate
Partial Response
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Objective Response Rate
Stable Disease
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Objective Response Rate
Progression
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment (Vorinostat and Isotretinoin)
Serious events: 11 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Vorinostat and Isotretinoin)
n=12 participants at risk
Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
|---|---|
|
General disorders
Fatigue
|
16.7%
2/12 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Anxiety
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Depression
|
8.3%
1/12 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Vorinostat and Isotretinoin)
n=12 participants at risk
Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
vorinostat: Given orally
isotretinoin: Given orally
|
|---|---|
|
General disorders
Weight Loss
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
25.0%
3/12 • Number of events 3
|
Additional Information
Lisa Escobar-Peralta, Program Manager
Montefiore Medical Center
Phone: 718-379-6866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60