Fibrosis Clinical Trial
Official title:
Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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