Back to resultsVorinostat and Palliative Radiotherapy (PRAVO)
Primary Purpose
Pelvic Cancer, Radiotherapy
Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Vorinostat
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Cancer focused on measuring Palliative treatment, Max. tolerable dose
Eligibility Criteria
Inclusion Criteria:
- Pelvic malignancy
- Palliative radiation treatment planed
- ECOG <3
- Age>18 years
Exclusion Criteria:
- Previous pelvic radiotherapy
- Uncontrolled diarrhea
- Insulin-dependent diabetes mellitus
- BMI<18.5
Sites / Locations
- The Norwegian Radium Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A I
Arm Description
Study drug
Outcomes
Primary Outcome Measures
DLT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00455351
Brief Title
Vorinostat and Palliative Radiotherapy
Acronym
PRAVO
Official Title
Phase I Study on Suberoylanilide Hydroxyamic Acid (Vorinostat) a Histone Deacetylase Inhibitor, in Palliative Radiotherapy for Advanced Tumors.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase I study. Side-effects when combined with standard palliative radiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Cancer, Radiotherapy
Keywords
Palliative treatment, Max. tolerable dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A I
Arm Type
Experimental
Arm Description
Study drug
Intervention Type
Drug
Intervention Name(s)
Vorinostat
Intervention Description
Increasing dosing, phase I
Primary Outcome Measure Information:
Title
DLT
Time Frame
continously
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pelvic malignancy
Palliative radiation treatment planed
ECOG <3
Age>18 years
Exclusion Criteria:
Previous pelvic radiotherapy
Uncontrolled diarrhea
Insulin-dependent diabetes mellitus
BMI<18.5
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigbjørn Smeland, MD,PhD
Organizational Affiliation
Norwegian Radium Hospital
Official's Role
Study Director
Facility Information:
Facility Name
The Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
NO-0310
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
20378407
Citation
Ree AH, Dueland S, Folkvord S, Hole KH, Seierstad T, Johansen M, Abrahamsen TW, Flatmark K. Vorinostat, a histone deacetylase inhibitor, combined with pelvic palliative radiotherapy for gastrointestinal carcinoma: the Pelvic Radiation and Vorinostat (PRAVO) phase 1 study. Lancet Oncol. 2010 May;11(5):459-64. doi: 10.1016/S1470-2045(10)70058-9. Epub 2010 Apr 6.
Results Reference
result
PubMed Identifier
21473790
Citation
Bratland A, Dueland S, Hollywood D, Flatmark K, Ree AH. Gastrointestinal toxicity of vorinostat: reanalysis of phase 1 study results with emphasis on dose-volume effects of pelvic radiotherapy. Radiat Oncol. 2011 Apr 8;6:33. doi: 10.1186/1748-717X-6-33.
Results Reference
derived
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Vorinostat and Palliative Radiotherapy
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