Vorinostat and Palliative Radiotherapy - Full Text View

Vorinostat and Palliative Radiotherapy (PRAVO)

This study is currently recruiting participants.

Verified by Rikshospitalet HF, February 2009

First Received: April 2, 2007 Last Updated: February 25, 2009 History of Changes

Sponsored by:	Rikshospitalet HF
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00455351

Purpose

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

Condition	Intervention	Phase
Pelvic Cancer Radiotherapy	Drug: Vorinostat	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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 Radiation Therapy

Drug Information available for: Suberoylanilide hydroxamic acid

U.S. FDA Resources

Further study details as provided by Rikshospitalet HF:

Primary Outcome Measures:

DLT [ Time Frame: continously ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	February 2007
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A I: Experimental 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

Contacts

Contact: Svein Dueland, MD, Ph.D.	+4722934000	svein.dueland@radiumhospitalet.no
Contact: Kjersti Flatmark, MD,Ph.D.	+4722934000	kjersti.flatmark@radiumhospitalet.no

Locations

Norway
The Norwegian Radium Hospital	Recruiting
Oslo, Norway, NO-0310
Contact: Svein Dueland, MD, PhD +4722934000 svein.dueland@radiumhospitalet.no
Principal Investigator: Svein Dueland, MD,PhD

Sponsors and Collaborators

Rikshospitalet HF

Investigators

Study Director:

Sigbjørn Smeland, MD,PhD

The Norwegian Radium Hospital

More Information

No publications provided

Responsible Party:	Rikshospitalet-Radiumhospitalet HF ( Svein Dueland (PI) )
Study ID Numbers:	EudraCTnumber 2006-003631-76
Study First Received:	April 2, 2007
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00455351 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Rikshospitalet HF:

Palliative treatment
Max. tolerable dose

Study placed in the following topic categories:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Vorinostat
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Pelvic Neoplasms

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Vorinostat
Physiological Effects of Drugs
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Pelvic Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009