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Trial record 27 of 163 for:    ISOTRETINOIN

Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00324740
Recruitment Status : Terminated
First Posted : May 11, 2006
Results First Posted : November 24, 2015
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions Drug: vorinostat
Drug: isotretinoin
Enrollment 14
Recruitment Details A total of 14 patients were enrolled between June 2006 and September 2010
Pre-assignment Details  
Arm/Group Title Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg) Dose Level 2 Vorinostat (300mg) and Isotretinoin (0.375 mg/kg) Dose Level 3: Vorinostat (300mg) and Isotretinoin (0.5 mg/kg)
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 7 3 4
Completed 6 3 3
Not Completed 1 0 1
Reason Not Completed
Withdrawal by Subject             1             0             1
Arm/Group Title Treatment (Vorinostat and Isotretinoin)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
55
(33 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
9
  75.0%
Male
3
  25.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
White 6
Asian 1
Black 1
Native Hawaiin or other Pacific Islander 1
Unknown 3
1.Primary Outcome
Title Dose Limiting Toxicities Associated With Vorinostat Concurrently Administered With Isotretinoin
Hide Description 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
Time Frame Course 1, up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg) Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.375 mg/kg) Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.5 mg/kg)
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 6 3 3
Measure Type: Number
Unit of Measure: participants
1 0 0
2.Primary Outcome
Title Maximum Tolerated Dose of Vorinostat in Combination With Isotretinoin
Hide Description 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.
Time Frame Once 2 DLT events occur in patients, the preceding dose will be designated the maximum tolerated dose (MTD).
Hide Outcome Measure Data
Hide Analysis Population Description
The recommended phase II dose is vorinostat (300 mg bid) + Isotretinoin (0.5 mg/kg PO bid) three days per week
Arm/Group Title Treatment (Vorinostat and Isotretinoin)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: mg/kg BID
0.5
3.Primary Outcome
Title Objective Response Rate
Hide Description The phase II portion of the study ended early therefore the primary outcome of the objective response rate was not assessed.
Time Frame Tumor measurements every 8 weeks until disease progression
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Vorinostat and Isotretinoin)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Vorinostat and Isotretinoin)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Vorinostat and Isotretinoin)
Affected / at Risk (%) # Events
Total   11/12 (91.67%)    
Blood and lymphatic system disorders   
Anemia  1/12 (8.33%)  1
Gastrointestinal disorders   
Dehydration  1/12 (8.33%)  1
Diarrhea  1/12 (8.33%)  1
Nausea  1/12 (8.33%)  1
Vomiting  1/12 (8.33%)  1
General disorders   
Fatigue  2/12 (16.67%)  2
Musculoskeletal and connective tissue disorders   
Muscle cramps  1/12 (8.33%)  1
Nervous system disorders   
Anxiety  1/12 (8.33%)  1
Depression  1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
Rash  1/12 (8.33%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Vorinostat and Isotretinoin)
Affected / at Risk (%) # Events
Total   4/12 (33.33%)    
Gastrointestinal disorders   
Anorexia  3/12 (25.00%)  3
General disorders   
Weight Loss  1/12 (8.33%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lisa Escobar-Peralta, Program Manager
Organization: Montefiore Medical Center
Phone: 718-379-6866
EMail: lescobar@montefiore.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00324740     History of Changes
Other Study ID Numbers: NCI-2009-00095
NCI-2009-00095 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-6896 ( Other Identifier: NCI/CTEP )
N01CM62204 ( U.S. NIH Grant/Contract )
P30CA013330 ( U.S. NIH Grant/Contract )
First Submitted: May 10, 2006
First Posted: May 11, 2006
Results First Submitted: July 20, 2015
Results First Posted: November 24, 2015
Last Update Posted: November 24, 2015