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


Phase 2
N/A
N/A
Not Enrolling
Both
Fibrosis, Radiation Injuries

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

950138

NCT ID:

NCT00001437

Start Date:

June 1995

Completion Date:

March 2000

Related Keywords:

  • Fibrosis
  • Radiation Injuries
  • Cytokines
  • Fibrosis Intensity
  • Post-Radiation Fibrosis
  • Radiation Injury
  • Trental
  • Fibrosis
  • Radiation Injuries

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892