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Study of the Combination of Vorinostat and Radiation Therapy for the Treatment of Patients With Brain Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00838929
First received: February 6, 2009
Last updated: April 15, 2014
Last verified: April 2014
Results First Received: March 14, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Brain Metastases
Interventions: Drug: Vorinostat
Radiation: Radiation Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vorinostat (200 mg) and Radiation

Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.

Vorinostat : All doses given for 3 weeks

Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd

Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation.

Vorinostat (300 mg) and Radiation No text entered.
Vorinostat (400 mg) and Radiation No text entered.

Participant Flow:   Overall Study
    Vorinostat (200 mg) and Radiation     Vorinostat (300 mg) and Radiation     Vorinostat (400 mg) and Radiation  
STARTED     3     8     6  
COMPLETED     3     5     5  
NOT COMPLETED     0     3     1  
Protocol Violation                 0                 1                 0  
Disease progression                 0                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Vorinostat (200 mg) and Radiation

Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.

Vorinostat : All doses given for 3 weeks

Dose level I - 200 mg PO qd (initial starting dose)

Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation.

Vorinostat (300 mg) and Radiation

Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.

Vorinostat : All doses given for 3 weeks

Dose level II - 300 mg PO qd

Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation.

Vorinostat (400 mg) and Radiation

Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.

Vorinostat : All doses given for 3 weeks

Dose level III - 400 mg PO qd

Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation.

Total Total of all reporting groups

Baseline Measures
    Vorinostat (200 mg) and Radiation     Vorinostat (300 mg) and Radiation     Vorinostat (400 mg) and Radiation     Total  
Number of Participants  
[units: participants]
  3     8     6     17  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     0     5     5     10  
>=65 years     3     3     1     7  
Gender  
[units: participants]
       
Female     1     5     3     9  
Male     2     3     3     8  
Region of Enrollment  
[units: participants]
       
United States     3     8     6     17  



  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Vorinostat and Radiotherapy in Patients With Brain Metastases.   [ Time Frame: Weekly during treatment On Last day of treatment (30 days after last drug dose) Follow-up (every 3 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Wenyin Shi, MD, PhD
Organization: Thomas Jefferson University
phone: 215-955-4111
e-mail: Wenyin.Shi.@jefferson.edu


No publications provided


Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00838929     History of Changes
Other Study ID Numbers: 08D.522, 2008-19
Study First Received: February 6, 2009
Results First Received: March 14, 2013
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board