Safety of Pentoxifylline and Vitamin E With Stereotactic Ablative Radiotherapy (SABR) in Non-small Cell Lung Cancers

NCT01871454 | Recruiting Phase 2 DMC

• 1 other identifier: BCC-RAD-13-Pentoxifylline
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this prospective phase II protocol is to assess the toxicity and efficacy of pentoxifylline and SABR in the re-treatment of recurrent or new lung cancers

Conditions

Non-small Cell Lung Cancers

Outcome Measures

Primary Outcomes (1)

• primary endpoint is to estimate overall treatment-related toxicity

  36 months-end of trial

Secondary Outcomes (3)

• Estimate progression free survival

  12 months

• Estimate tumor failure

  12 months

• estimate overall survival

  12 months

Study Arms (1)

radiotherapy (SABR) plus pentoxifylline

EXPERIMENTAL

standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E

Radiation: stereotactic ablative radiotherapy (SABR); Drug: Pentoxifylline

Interventions

stereotactic ablative radiotherapy (SABR) RADIATION

standard of care radiation therapy

radiotherapy (SABR) plus pentoxifylline

Pentoxifylline DRUG

pentoxifylline

radiotherapy (SABR) plus pentoxifylline

Eligibility Criteria

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

You may qualify if:

• Age \>/= 18 years
• ECOG performance status 0-1 3.1.3 Histologically proven diagnosis of a prior thoracic malignancy treated with thoracic external beam radiotherapy with or without systemic chemotherapy
• Pathologic or clinical diagnosis of a new or loco-regional recurrent lung malignancy. A reasonable attempt should be made to make a pathologic diagnosis of malignancy (ie. bronchoscopy, CT guided lung biopsy)
• Loco-regional is defined as recurrence within the region of the primary tumor or adjacent draining lymph node regions.
• The new lesion or loco-regional recurrence must be within or adjacent to the previously irradiated treatment volume.
• Imaging as follows:
• CT scan of the chest with IV contrast within 8 weeks of registration
• Whole body PET scan within 8 weeks of registration
• Pulmonary function test (PFTs), including diffusion capacity within 8 weeks of registration
• Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
• Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
• Patients must provide study specific informed consent prior to study entry.

You may not qualify if:

• No previously reported thoracic radiotherapy
• FEV1 \<20% predicted and/or DLCO \<20% predicted
• Pregnant women or lactating women
• Chemotherapy within 4 weeks of the initiation of SABR
• Plans to administer systemic chemotherapy overlapping with radiotherapy

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center, U of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Interventions

Pentoxifylline

Intervention Hierarchy (Ancestors)

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

Study Officials

• Neal E Dunlap, MD

  James Graham Brown Cancer Center-U of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

US (1)