We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001437
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  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 2

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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001437


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

ClinicalTrials.gov Identifier: NCT00001437     History of Changes
Other Study ID Numbers: 950138
95-C-0138
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: May 1999

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

Additional relevant MeSH terms:
Fibrosis
Radiation Injuries
Pathologic Processes
Wounds and Injuries
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants