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Anti-microtubule agent

Intravesical Abraxane for Bladder Cancer (Abraxane Trial)

Phase 1 & 2

Waitlist Available

Led By James M McKiernan, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled

Age > 18 and must be able to read, understand and sign informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 4 months, 6 months

Awards & highlights

Abraxane Trial Summary

This trial is designed to test the safety, toxicity, and efficacy of Abraxane for the treatment of recurrent transitional cell cancer of the urinary bladder. The trial will enroll a maximum of 18 patients in 3 cohorts. Dose increases will occur in groups of three patients, with each successive group receiving an increased concentration of Abraxane intravesically. No dose increase will occur until each member of the previous cohort has undergone the first instillation of the medication without experiencing a dose-limiting toxicity (DLT). The trial will be considered a successful if at any point in the study, there have been a total of 6 or more successes.

Who is the study for?

This trial is for adults over 18 with recurrent bladder cancer that hasn't spread to muscle, and who haven't responded to standard treatments like BCG or mitomycin. They must have good blood counts, liver and kidney function, no severe nerve damage, not be pregnant or breastfeeding, and agree to use effective contraception. People can't join if they've had certain other cancers recently, previous treatment with drugs similar to Abraxane, concurrent chemotherapy, or a history of urinary reflux/stent.Check my eligibility

What is being tested?

The trial tests the safety and effectiveness of Abraxane delivered directly into the bladder for those whose cancer persists after standard therapy. It starts by gradually increasing doses in groups until side effects become too strong (Phase I), then moves on to see if it works well enough in a larger group (Phase II).See study design

What are the potential side effects?

Potential side effects include dose-limiting toxicities which could lead to removal from the study; these may involve reactions at the site of instillation within the bladder or systemic effects due to absorption of the drug.

Abraxane Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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All visible signs of my disease were surgically removed.

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I am over 18 and can understand and sign the consent form.

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I am fully active or can carry out light work.

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My bladder cancer diagnosis has been confirmed by the study's hospital.

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I am capable of becoming pregnant and have a negative pregnancy test.

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I have not had radiation treatment to my pelvic area.

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My kidney function is good with a creatinine level of 2.0 mg/dL or less.

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My nerve damage symptoms are very mild or non-existent.

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My early-stage cancer is confirmed to be aggressive.

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My bladder cancer has come back and is not responding to standard treatments, but it has not spread into the muscle.

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My bladder cancer came back after standard treatments like BCG.

Abraxane Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 4 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 4 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 4 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose.

To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory superficial TCC as measured by response rate (defined as negative cytology and bladder biopsy).

Secondary outcome measures

To further evaluate the safety and toxicity profile of intravesically administered Abraxane therapy.

Abraxane Trial Design

1Treatment groups

Experimental Treatment

Group I: Abraxane administrationExperimental Treatment1 Intervention

Patients will restrict their fluid intakes the morning of treatments and will have emptied their bladders at each of their visits and have up to 100ml of Abraxane solution administered to their bladder via urinary catheter once weekly for six weeks.

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,784 Total Patients Enrolled

Celgene CorporationIndustry Sponsor

444 Previous Clinical Trials

58,189 Total Patients Enrolled

James M McKiernan, MDPrincipal InvestigatorColumbia University Medical Center, Urology

Media Library

Bladder Cancer Research Study Groups: Abraxane administration

Bladder Cancer Clinical Trial 2023: Paclitaxel, nanoparticle albumin-bound Highlights & Side Effects. Trial Name: NCT00583349 — Phase 1 & 2

Paclitaxel, nanoparticle albumin-bound (Anti-microtubule agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00583349 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there many instances in which Paclitaxel, nanoparticle albumin-bound has been studied?

"At present, 900 active trials are researching Paclitaxel, nanoparticle albumin-bound with 238 of those trials in Phase 3. While some of the studies for Paclitaxel, nanoparticle albumin-bound are finishing up in Woolloongabba, Queensland, there are 46338 other locations around the world where trials for this medication are still ongoing."

Answered by AI

What type of cancer does Paclitaxel, nanoparticle albumin-bound help patients with the most?

"Conditions such as hypoalbuminemia, acute pyelonephritis(apn), and shock, hypovolemic can be mitigated through Paclitaxel, nanoparticle albumin-bound treatments."

Answered by AI

To what extent is this experiment's sample size sufficient?

"Unfortunately, this particular trial is not taking any more patients at the moment. It was first posted on December 1st 2007 and edited for the last time on November 2nd 2012. There are other trials that might be of interest; 393 clinical trials for urinary bladder cancer and 900 for Paclitaxel, nanoparticle albumin-bound are still recruiting patients."

Answered by AI

Are we recruiting patients for this trial at the moment?

"Unfortunately, this particular clinical trial is not currently recruiting new patients. Although the last update was on November 2nd 2012, originally this study was posted December 1st 2007. There are 1293 other studies that may be of interest and are actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I & II Trial of Intravesicular Abraxane for Treatment-refractory Bladder Cancer

2007. "Phase I & II Trial of Intravesicular Abraxane for Treatment-refractory Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00583349.

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