Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibrosis; Radiation Injuries
Intervention: pentoxifylline (Drug)
Phase: Phase 2
Sponsored by: National Cancer Institute (NCI)
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.
Official title: Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
Study design: Treatment, Safety/Efficacy Study
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.
Minimum age: N/A.
Maximum age: N/A.
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
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.
Age: 18 and over.
Performance status: Karnofsky 70%-100% (unrelated to postradiation fibrosis).
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.
No intolerance to pentoxifylline or other xanthines (e. g., caffeine, theophylline,
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.
Locations and Contacts
National Cancer Institute (NCI), Bethesda, Maryland 20892, United States
Starting date: June 1995
Ending date: March 2000
Last updated: March 3, 2008