Your session is about to expire
← Back to Search
Other
SABR + Pentoxifylline/Vitamin E for Lung Cancer
Phase 2
Recruiting
Led By Neal E Dunlap, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-1
Age >/= 18 years
Must not have
Chemotherapy within 4 weeks of the initiation of SABR
Plans to administer systemic chemotherapy overlapping with radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial is testing a combination of a blood flow medication and precise radiation therapy on patients with recurring or new lung cancers. The goal is to see if this combination is safe and effective.
Who is the study for?
This trial is for adults over 18 with a history of thoracic cancer treated previously, who now have new or recurrent lung malignancies. They should be in good physical condition (ECOG 0-1), not pregnant, willing to use birth control, and have had recent scans and pulmonary tests. Those with very poor lung function or recent chemotherapy are excluded.
What is being tested?
The study is examining the safety and effectiveness of combining Pentoxifylline medication with Stereotactic Ablative Radiotherapy (SABR) for treating new or returning lung cancers that were previously irradiated.
What are the potential side effects?
Potential side effects may include typical reactions to radiotherapy like skin irritation, fatigue, difficulty swallowing if the esophagus is affected, as well as possible risks associated with Pentoxifylline such as dizziness, nausea, or gastrointestinal upset.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
Select...
I had cancer in my chest area treated with radiation, with or without chemotherapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had chemotherapy in the last 4 weeks.
Select...
I will be receiving chemotherapy at the same time as radiotherapy.
Select...
I have never had radiation therapy to my chest.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: radiotherapy (SABR) plus pentoxifyllineExperimental Treatment2 Interventions
standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pentoxifylline
FDA approved
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
348 Previous Clinical Trials
77,319 Total Patients Enrolled
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,137 Total Patients Enrolled
Neal E Dunlap, MDPrincipal InvestigatorJames Graham Brown Cancer Center-U of Louisville
2 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I haven't had chemotherapy in the last 4 weeks.My lung cancer is newly diagnosed or has come back in the same area.I have never had radiation therapy to my chest.I will be receiving chemotherapy at the same time as radiotherapy.I am 18 years old or older.I had cancer in my chest area treated with radiation, with or without chemotherapy.Your lung function test results are very low, showing that you have severe breathing problems.
Research Study Groups:
This trial has the following groups:- Group 1: radiotherapy (SABR) plus pentoxifylline
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.