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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

Must not have

Any other malignancy diagnosed within 2 years of study entry (except basal or squamous cell skin cancers or non-invasive cancer of the cervix) is excluded

History of neuropathy of any cause

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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).

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been diagnosed with any cancer other than skin or non-invasive cervical cancer in the last 2 years.

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I have had nerve damage in the past.

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I am currently not on any chemotherapy treatments.

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I am not pregnant or breastfeeding.

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I have previously been treated with docetaxel or paclitaxel.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

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.

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 / 16Eligibility criteria met