Recruiting

Study of Clofarabine for Patients with Advanced or Metastatic Bladder Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called urothelial carcinoma, which affects the lining of the urinary system, including the bladder. The study is testing a treatment using a medication called clofarabine, which is given as an infusion directly into the bloodstream. The purpose of the study is to find the highest dose of clofarabine that patients can tolerate without severe side effects.

Participants in the study will receive clofarabine in increasing doses to determine the safest and most effective amount. The study will monitor how the cancer responds to the treatment and how long any positive effects last. Researchers will also observe how the cancer progresses over time and the overall survival of participants. Additionally, the study will track any side effects related to the treatment.

The trial will also gather information on how clofarabine behaves in the body, such as how much of the drug is present in the blood at different times. This information will help in understanding the best way to use clofarabine for treating urothelial carcinoma in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the information provided.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting tests to ensure you meet the study's criteria, such as having a confirmed diagnosis of urothelial carcinoma and adequate organ function.
Step 3
Treatment phase
During the treatment phase, you will receive the medication clofarabine through an intravenous infusion. This means the medication will be administered directly into your vein. The dosage and frequency will be determined based on the study's design to find the maximum tolerated dose.
You will be monitored closely for any side effects or reactions to the medication. Regular check-ups and tests will be conducted to assess your response to the treatment.
Step 4
Follow-up assessments
After completing the treatment phase, follow-up assessments will be scheduled. These assessments will help determine the effectiveness of the treatment and monitor any long-term effects.
You will undergo various tests, including imaging studies, to evaluate the response of your cancer to the treatment.
Step 5
End of study participation
At the end of your participation in the study, a final assessment will be conducted. This will include a review of your overall health and any changes observed during the trial.
You will receive information on any further steps or treatments that may be recommended based on the study's findings.

Who can join the trial?

14 criteria

Patients must have a confirmed diagnosis of urothelial carcinoma, which is a type of cancer, and it must be either spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable locally advanced disease).
Patients must have adequate kidney function. This means their blood test should show a serum creatinine level of 1.0 mg/dL or less. If it's higher, their estimated kidney filtration rate (GFR) should be more than 60 mL/min/1.73 m².
Patients must have adequate heart function. This means they should not have severe heart problems classified as NYHA class III or IV.
Both male and female patients must use an effective method of birth control during the study and for at least 6 months after the study treatment ends.
Female patients who can have children must have a negative pregnancy test within 2 weeks before joining the study.
Patients must be willing and able to provide informed consent, which means they agree to participate after understanding the study details.
Patients should have already received standard treatment for their condition and not benefited from it, or they must have refused standard therapy.
Patients must be 18 years or older.
Patients must have an ECOG performance status of 0 to 2, which is a scale that measures how well they can perform daily activities.
Patients must have an absolute neutrophil count (ANC) of 1500 or more. Neutrophils are a type of white blood cell important for fighting infections.
Patients must have a white blood cell (WBC) count greater than 3.0.
Patients must have platelets of 100 or more. Platelets help with blood clotting.
Patients must have hemoglobin levels greater than 9.0 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.
Patients must have adequate liver function. This means their total bilirubin should be 1.5 times the upper limit of normal or less, and their liver enzymes (AST and ALT) should be 2.5 times the upper limit of normal or less.

Who cannot join the trial?

8 criteria

Patients with any other type of cancer besides **urothelial carcinoma** cannot participate.
Patients who have had another cancer treatment within the last 4 weeks are not eligible.
Patients with severe heart problems cannot join the study.
Patients with uncontrolled infections are not allowed to participate.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients with a history of severe allergic reactions to similar drugs are excluded.
Patients with significant liver or kidney disease cannot participate.
Patients who are unable to follow the study procedures are not eligible.

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Verified sites

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Medical University Of Vienna
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Vienna, Austria

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Investigated drugs

Clofarabine is a medication being studied for its potential use in treating urothelial carcinoma, which is a type of cancer that affects the bladder and other parts of the urinary system. In this clinical trial, researchers are trying to find out the highest dose of Clofarabine that patients can tolerate without severe side effects. The goal is to see if Clofarabine can help control or reduce the cancer in patients whose disease is locally advanced or has spread to other parts of the body.

Clofarabine

What is already known about the treatment

Clofarabine – Clofarabine is administered intravenously, meaning it is given through a vein, typically in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating urothelial carcinoma, a type of bladder cancer. The main goal of these trials is to determine the highest dose that patients can tolerate without severe side effects. Clofarabine works by interfering with the DNA of cancer cells, preventing them from growing and multiplying. It is classified as an antineoplastic agent, which is a type of medication used to treat cancer.

Investigated diseases

Urothelial carcinoma – Urothelial carcinoma is a type of cancer that occurs in the urothelial cells lining the bladder and other parts of the urinary tract. It typically begins in the bladder but can also affect the ureters and renal pelvis. The disease progresses as cancer cells grow uncontrollably, forming tumors that can invade deeper layers of the bladder wall and potentially spread to nearby tissues and organs. As it advances, it may cause symptoms such as blood in the urine, frequent urination, and pain during urination. The progression can vary, with some cases remaining superficial while others become invasive. The disease's behavior depends on factors like tumor grade and stage.