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

History of Changes

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:

MedlinePlus related topics: Cancer

Drug Information available for: Vorinostat

U.S. FDA Resources

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

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:

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. Epub 2010 Apr 6.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013

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