Vorinostat and Palliative Radiotherapy

Radiotherapy Clinical Trial

— PRAVO  

Official title:

Phase I Study on Suberoylanilide Hydroxyamic Acid (Vorinostat) a Histone Deacetylase Inhibitor, in Palliative Radiotherapy for Advanced Tumors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455351
• Other study ID #: EudraCTnumber 2006-003631-76
• Status: Completed
• Phase: Phase 1
• Start date: February 2007
• Est. completion date: August 2009

Study information

• Verified date: May 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase I study. Side-effects when combined with standard palliative radiotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Cancer
• Pelvic Neoplasms
• Radiotherapy

Intervention

Drug:
• Vorinostat
Increasing dosing, phase I

Locations

Country	Name	City	State
Norway	The Norwegian Radium Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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 (PRAV — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT		continously