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Anti-metabolites
mFOLFIRINOX + Hydroxychloroquine for Pancreatic Cancer
Phase 1 & 2
Recruiting
Led By Brian Boone, MD
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with biopsy-proven adenocarcinoma of the pancreas
No active second malignancy except for basal cell carcinoma of the skin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months
Awards & highlights
Study Summary
This trial will examine the safety and tolerability of a combination of two drugs, one given before surgery and one given after, in treating pancreatic cancer.
Who is the study for?
This trial is for adults with resectable pancreatic adenocarcinoma, confirmed by biopsy and CT scan without vein or artery involvement. Participants must have normal kidney, liver, and blood function; no severe allergies to study drugs; not be on certain anti-epileptic medications; and have no history of macular degeneration or diabetic retinopathy. Pregnant women are excluded, as well as those with HIV, porphyria, uncontrolled psoriasis, recent chemotherapy within the last year or other concurrent experimental therapies.Check my eligibility
What is being tested?
The trial tests the safety of combining mFOLFIRINOX (a chemotherapy mix) with oral hydroxychloroquine before surgery in patients with pancreatic cancer. The treatment aims to improve surgical outcomes and will be followed by standard care adjuvant therapy post-surgery. Patients' tissue samples will also be studied for future research on autophagy's role in tumor response.See study design
What are the potential side effects?
Potential side effects include reactions related to each component of mFOLFIRINOX—such as nausea from oxaliplatin—and hydroxychloroquine-related issues like vision changes or skin rashes. There may also be general chemo side effects like fatigue, lowered immunity leading to infections, bleeding complications due to low platelet counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with pancreatic adenocarcinoma.
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I have no active cancer except possibly skin cancer.
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My obstructive jaundice is managed with a biliary stent.
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I am fully active and can carry on all my pre-disease activities without restriction.
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My CT scan shows my pancreatic cancer can be surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I - Establishing Maximum tolerated dose (MTD)
Phase II - Rate of grade IIb or better histopathological response
Secondary outcome measures
Phase II - To establish the potential biological activity of FHQ by biochemical tumor response, as assessed by Ca 19-9.
Trial Design
1Treatment groups
Experimental Treatment
Group I: HydroxychloroquineExperimental Treatment1 Intervention
Hydroxychloroquine sulfate
Find a Location
Who is running the clinical trial?
West Virginia UniversityLead Sponsor
176 Previous Clinical Trials
60,174 Total Patients Enrolled
Brian Boone, MDPrincipal Investigator - WVU Cancer Institute
Medical School - Wake Forest University
University of Pittsburgh, Residency in Dermatology
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My scans show cancer near major blood vessels in my liver, making surgery difficult.My psoriasis is under control and monitored by a specialist.I am not taking any epilepsy medication like phenytoin or carbamazepine.I agree to use birth control during the study and will report any pregnancies.I have genetic mutations increasing my risk of chemotherapy side effects.I do not have porphyria.I have been diagnosed with pancreatic adenocarcinoma.I have no active cancer except possibly skin cancer.My obstructive jaundice is managed with a biliary stent.My cancer has spread to distant organs like the liver, lung, or abdomen.I have had chemotherapy within the last year.I am fully active and can carry on all my pre-disease activities without restriction.I do not have HIV.My kidney, liver, and blood tests are normal.I have had radiotherapy or tried new treatments for pancreatic cancer.I am not allergic to chloroquine, hydroxychloroquine, or certain chemotherapy drugs.My CT scan shows my pancreatic cancer can be surgically removed.My condition cannot be treated with surgery or I choose not to have surgery.I do not have macular degeneration or diabetic retinopathy.I have symptoms or test results showing a blockage in my stomach's exit.I do not have any active cancer except for basal cell skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Hydroxychloroquine
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What primary purpose does Hydroxychloroquine sulfate serve in medicine?
"A common treatment for malaria is Hydroxychloroquine sulfate, which can also be beneficial in treating q fever, rheumatoid arthritis and sjögren's syndrome."
Answered by AI
Do any openings remain for prospective participants in this investigation?
"As evidenced on clinicaltrials.gov, this medical investigation is still in search of volunteers. Since its initial posting on July 16th 2021, the study has been revised as recently as October 24th 2022."
Answered by AI
How many participants are being monitored as part of this scientific investigation?
"Affirmative. The clinicaltrial.gov page suggests that this medical research project, which was initially published on July 16th 2021 is currently recruiting patients. There are 40 positions available at a single facility."
Answered by AI
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