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Alkylating Agent
Celecoxib + Chemotherapy for Bladder Cancer (BLAST Trial)
Phase 1
Waitlist Available
Led By Aihua Edward Yen, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have tumor tissues from transurethral resection of the bladder tumor (TURBT) that is within 120 days of registration and available for submission. Tissue sample must be sufficient for IHC testing; that is,it must be sufficient tumor tissues for correlative science after pathologic diagnosis [i.e., enough tumor tissue to pass the staging criteria in 4c].
Patients must have a Zubrod performance status of 0, 1 or 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
BLAST Trial Summary
This trial will compare gene expression in tumor tissue of patients before and after treatment with chemotherapy plus celecoxib, to see if celecoxib has any effect on tumor cells.
Who is the study for?
This trial is for adults with localized, muscle-invasive bladder cancer who haven't had systemic chemotherapy. They need recent scans and tests showing good organ function, no severe neuropathy or uncontrolled illnesses, not pregnant/nursing, and can't be regularly using NSAIDs or have a history of significant bleeding or heart issues.Check my eligibility
What is being tested?
The study is testing the effects of adding Celecoxib to standard chemotherapy (Cisplatin and Gemcitabine) on bladder cancer tissue. Researchers will compare gene expression in tumor samples taken before and after treatment to see how Celecoxib affects the cells.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy like nausea, fatigue, hair loss; plus risks from Celecoxib such as stomach upset, kidney problems, increased risk of heart attack/stroke. Cisplatin may cause nerve damage and hearing changes.
BLAST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a recent bladder tumor tissue sample from surgery ready for testing.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
My tumor is invasive, measures at least 10mm, or causes kidney swelling.
Select...
I've had the required scans and tests for cancer staging within the last 56 days.
Select...
I am 18 years old or older.
Select...
My bladder cancer diagnosis includes urothelial carcinoma, possibly with other types but not purely small cell, adenocarcinoma, or squamous cell.
Select...
My liver is functioning well according to recent tests.
BLAST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number and severity of adverse events
RNA, Messenger
Secondary outcome measures
Pathological disease stage at cystectomy, including the rate of pT0 and the rate of < pT2.
Two-year overall survival
Two-year progression free survival
Other outcome measures
Changes Cytokeratin 14 and phospho-histone H3 (proliferation markers)
Changes in COX2 IHC staining
Changes in gene expression signatures in association with therapeutic response
Side effects data
From 2010 Phase 2 trial • 255 Patients • NCT010621135%
Beta 2 microglobulin increased
3%
Beta-N-acetyl-D-glucosaminidase increased
3%
Blood bilirubin increased
2%
Eczema
1%
White blood cell count increased
1%
Blood urine present
1%
Hypoaesthesia facial
1%
Rash
1%
Post procedural haemorrhage
1%
Blood creatine phosphokinase increased
1%
Blood phosphorus decreased
1%
Urobilin urine present
1%
Presyncope
1%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Initial Dose Celecoxib 400 mg
Additional Dose Placebo
Additional Dose Celecoxib 200 mg
BLAST Trial Design
1Treatment groups
Experimental Treatment
Group I: Celecoxib plus Gemcitabine/Cisplatin chemoExperimental Treatment3 Interventions
Celecoxib plus Gemcitabine/Cisplatin neoadjuvant chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Celecoxib
FDA approved
Gemcitabine
FDA approved
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,397 Total Patients Enrolled
Aihua Edward Yen, MD5.01 ReviewsPrincipal Investigator - Baylor College of Medicine
Baylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had serious bleeding issues in the last 6 months.You cannot have asthma that is sensitive to aspirin.I haven't had a stroke, heart attack, or severe angina in the last 6 months.I can take care of myself and am up and about more than 50% of my waking hours.Your blood tests must show: i. a certain amount of white blood cells, ii. a certain level of hemoglobin, and iii. a certain number of platelets.My tumor is invasive, measures at least 10mm, or causes kidney swelling.I don't regularly use NSAIDs more than twice a week or aspirin over 325 mg three times a week.My heart functions well and I do not have severe heart failure.I have a recent bladder tumor tissue sample from surgery ready for testing.I do not have severe numbness or pain in my hands or feet.I have not had chemotherapy for bladder cancer.My doctor thinks I can be treated with gemcitabine/cisplatin.I've had the required scans and tests for cancer staging within the last 56 days.I am 18 years old or older.I am not allergic to cisplatin, gemcitabine, or celecoxib.My bladder cancer is at a specific stage and I've had recent tests to confirm this.I do not have any uncontrolled illnesses that could interfere with the study.I am not pregnant or nursing and agree to use birth control during and for 6 months after treatment.My liver is functioning well according to recent tests.I have been on stable blood thinners since my clot or lung blockage in the last 6 months.My bladder cancer diagnosis includes urothelial carcinoma, possibly with other types but not purely small cell, adenocarcinoma, or squamous cell.My kidney function is good, with a creatinine clearance rate of at least 50 mL/min.
Research Study Groups:
This trial has the following groups:- Group 1: Celecoxib plus Gemcitabine/Cisplatin chemo
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 is the upper bound of participants in this medical trial?
"Affirmative. The clinical trial portal lists this medical study, which was initially posted on December 1st of 2016, as actively recruiting participants. 15 individuals are being recruited from 2 separate locations for the experiment in question."
Answered by AI
Are there any adverse effects associated with Celecoxib usage?
"Celecoxib's safety is rated with a score of 1 on the scale, as this early-stage trial has yet to produce substantial data in favor of its efficacy or harmlessness."
Answered by AI
What conditions does Celecoxib typically address?
"Celecoxib has been found to be a very effective treatment for neoplasm metastasis, as well as small cell lung cancer (SCLC), urinary bladder issues, and advanced testicular cancer."
Answered by AI
Is the enrollment window still available for this trial?
"Affirmative. According to clinicaltrials.gov, this research is searching for potential participants, with the original post date being December 1st 2016 and last update on July 22nd 2022. Two medical sites are recruiting 15 patients in total."
Answered by AI
What other research has been conducted to assess the efficacy of Celecoxib?
"Currently, the drug Celecoxib is being investigated in 1011 distinct trials with 341 of them located in Phase 3. Of these studies, 53835 sites around the globe are taking place. Notably, several locations are based out of Shanghai alone."
Answered by AI
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