Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001437
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
Status:
COMPLETED
Status Verified Date:
1999-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-C-0138 | None | None | None |