search
Back to results

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

Primary Purpose

Fibrosis, Radiation Injuries

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pentoxifylline
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrosis focused on measuring Cytokines, Fibrosis Intensity, Post-Radiation Fibrosis, Radiation Injury, Trental

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001437
Brief Title
Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
Official Title
Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 1999
Overall Recruitment Status
Completed
Study Start Date
June 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosis, Radiation Injuries
Keywords
Cytokines, Fibrosis Intensity, Post-Radiation Fibrosis, Radiation Injury, Trental

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pentoxifylline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs