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

NCT00001437 | Completed Phase 2

• 2 other identifiers: 95013895-C-0138
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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). Objective and subjective response parameters will be re-assessed at the end of the treatment and 8 weeks later for possible decay of response.

Conditions

Fibrosis; Radiation Injuries

Keywords

Cytokines; Fibrosis Intensity; Post-Radiation Fibrosis; Radiation Injury; Trental

Interventions

pentoxifylline DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Fibrosis; Radiation Injuries

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: June 1, 1995
• Study Completion: March 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-05

Locations

US (1)