Status:
COMPLETED
Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Fibrosis
Radiation Injuries
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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). Objec...
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 ...
Eligibility 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.
Key Trial Info
Start Date :
June 1 1995
Trial Type :
INTERVENTIONAL
End Date :
March 1 2000
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00001437
Start Date
June 1 1995
End Date
March 1 2000
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892