ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis

This study has been completed.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001437
  Purpose

After initial assessment of their condition by specified clinical and laboratory parameters, each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg po TID). Objective and subjective response parameters will be re-assessed at the end of the treatment and 8 weeks later for possible decay of response.


Condition Intervention Phase
Fibrosis
Radiation Injuries
Drug: pentoxifylline
Phase II

ChemIDplus related topics:   Pentoxifylline    Pentoxyl   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety/Efficacy Study
Official Title:   Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   50
Study Start Date:   June 1995
Estimated Study Completion Date:   March 2000

Detailed Description:

Patients with late fibrovascular sequelae of radiation or of combined radiation and surgery, with quantifiable symptomatology or disability, will be eligible for this trial. This protocol is designed as an open label one arm study. (A placebo controlled randomized trial was approved by the IRB but after extensive negotiation, drug and placebo in slow release formulation will not be provided by the manufacturer). Up to fifty patients will be recruited. After initial assessment of their condition by specified clinical and laboratory parameters, each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg po TID). Objective and subjective response parameters will be re-assessed at the end of the treatment and 8 weeks later for possible decay of response.

In addition to symptomatic objective and subjective response, blood and urine will be collected for TNF, TGF-beta, and FGF. Cutaneous blood flow and collagen subtyping will be performed on a subset of patients using Laser Doppler, functional MRI techniques and subcutaneous tissue biopsies. We will examine for correlation between clinical response and these biological responses.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

POPULATION CHARACTERISTICS:

Regional advanced postradiation fibrosis of the neck, chest wall, pelvis, or extremities causing measurable impairment of specific function, i.e.: Decreased range of motion, Weakness, Sensory deficit, Pain requiring narcotics, Significantly altered activities of daily living.

None of these conditions present either before or during radiotherapy or attributed to surgery or chemotherapy.

Patients with prostate cancer allowed if prostate-specific antigen (PSA) is less than 4.0 ng/mL and the last 3 PSA values were stable or decreasing. Abnormal bone scan or film acceptable if consistent with degenerative disease.

No recurrent or metastatic cancer.

No concurrent second cancer.

PRIOR/CONCURRENT THERAPY: At least 3 months since pentoxifylline.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: Karnofsky 70%-100% (unrelated to postradiation fibrosis).

CARDIOVASCULAR:

No symptomatic coronary artery disease with frequent anginal episodes necessitating any of the following during past 6 months: Coronary artery bypass, Angioplasty, Pacemaker placement, Thrombolytic treatment.

No chronic cardiac failure with persistent hemodynamic abnormality and ejection fraction less than 40%.

No coagulation, platelet, or vascular disorder that threatens to cause bleeding.

OTHER:

No intolerance to pentoxifylline or other xanthines (e.g., caffeine, theophylline, theobromine).

No seizure disorder.

No peptic ulcer disease.

Willing to undergo serial evaluations (excluding biopsies, laser Doppler, MRI) by NCI rehabilitation specialist for documentation and grading of functional disability.

No pregnant or nursing women.

Adequate contraception encouraged in fertile women.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001437

Locations
United States, Maryland
National Cancer Institute (NCI)    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators
  More Information

Study ID Numbers:   950138, 95-C-0138
First Received:   November 3, 1999
Last Updated:   March 3, 2008
ClinicalTrials.gov Identifier:   NCT00001437
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cytokines  
Fibrosis Intensity  
Post-Radiation Fibrosis  
Radiation Injury  
Trental  

Study placed in the following topic categories:
Fibrosis
Wounds and Injuries
Disorders of Environmental Origin
Radiation Pneumonitis
Pentoxifylline
Radiation Injuries

Additional relevant MeSH terms:
Radiation-Protective Agents
Vasodilator Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Pathologic Processes
Phosphodiesterase Inhibitors
Therapeutic Uses
Free Radical Scavengers
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008




Links to all studies - primarily for crawlers