Vorinostat and Palliative Radiotherapy (PRAVO)

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00455351
First received: April 2, 2007
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Pelvic Cancer
Radiotherapy
Drug: Vorinostat
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study on Suberoylanilide Hydroxyamic Acid (Vorinostat) a Histone Deacetylase Inhibitor, in Palliative Radiotherapy for Advanced Tumors.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • DLT [ Time Frame: continously ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: February 2007
Study Completion Date: August 2009
Arms Assigned Interventions
Experimental: A I
Study drug
Drug: Vorinostat
Increasing dosing, phase I

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455351

Locations
Norway
The Norwegian Radium Hospital
Oslo, Norway, NO-0310
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Sigbjørn Smeland, MD,PhD Norwegian Radium Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Svein Dueland (PI), Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier: NCT00455351     History of Changes
Other Study ID Numbers: EudraCTnumber 2006-003631-76
Study First Received: April 2, 2007
Last Updated: July 21, 2011
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Palliative treatment
Max. tolerable dose

Additional relevant MeSH terms:
Pelvic Neoplasms
Neoplasms by Site
Neoplasms
Vorinostat
Histone Deacetylase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014