A Phase I Dose-Escalation Study of Clofarabine in Patients with Relapsed or Refractory Low-Grade or Intermediate-Grade B-Cell or T-Cell Lymphoma.
Francine Marie Foss, Terri Parker
https://pubmed.ncbi.nlm.nih.gov/29438091Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID07034053
Clofarabine Therapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma: a Phase 1/2 Dose-Escalation Study
Led by Ekaterina Laukhtina · Updated on 2025-06-26
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating clofarabine, a chemotherapy drug, in patients with advanced or metastatic urothelial carcinoma who have already received standard treatments. This phase 1/2 study aims to find the highest dose that patients can tolerate, understand how the drug moves through the body, and assess its safety and effectiveness. The study focuses on patients with confirmed urothelial cancer that is metastatic or locally advanced and not surgically removable. Participants receive intravenous clofarabine following a dose-escalation plan to determine the maximum tolerated dose. The study includes patients who have previously undergone standard care or refused it. The treatment period includes dosing cycles, with evaluations based on side effects and responses. The study monitors patients through dosing and for up to 90 days after the last dose for safety and tolerability. During the study, participants undergo various assessments including blood tests to check blood counts, liver and kidney function, and cardiac status. Researchers measure outcomes such as dose-limiting toxicities within the first 28 days, objective tumor responses, duration of response, progression-free survival, and overall survival over up to 36 months. Pharmacokinetic measures like drug concentration in the blood are also tracked. The study is expected to continue until November 2028, with participants closely monitored throughout.
CONDITIONS
Brief Title
Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytologically confirmed urothelial carcinoma, radiologically documented metastatic or unresectable locally advanced disease
- Patients who have already received standard treatment and did not benefit from it, or patients who have refused standard therapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) greater than or equal to 1500
- White blood cell (WBC) count greater than 3.0
- Platelets greater than or equal to 100
- Hemoglobin greater than 9.0 g/dL
- Adequate hepatobiliary function: total bilirubin ≤ 1.5 x upper limit of normal; AST and ALT ≤ 2.5 x upper limit of normal
- Adequate renal function: serum creatinine ≤ 1.0 mg/dL or estimated glomerular filtration rate (GFR) > 60 mL/min/1.73 m² if creatinine > 1.0 mg/dL
- Adequate cardiac function (excluding NYHA cardiac III-IV)
- Male and female patients must use effective contraception during the study and for at least 6 months after treatment
- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
- Willing and able to provide informed consent
You will not qualify if you...
- Prior treatment with clofarabine
- Current chemotherapy, radiation therapy, or immunotherapy
- Prior radiation therapy to the pelvis
- Participation in other investigational drug studies or receipt of investigational drugs within 30 days
- Severe concurrent disease or serious organ dysfunction involving heart, kidney, liver, or other organs that increases treatment risk
- New York Heart Association classification stage II, III, or IV congestive heart failure
- Coronary artery disease or arteriosclerotic cardiovascular disease within 3 months before study drug
- Other primary cardiac diseases increasing ventricular arrhythmia risk
- Uncontrolled systemic infections
- Chronic use of high-dose corticosteroids (over 1 mg/kg/day)
- Significant concurrent illness or psychiatric disorder affecting safety or compliance
- Diagnosis of another malignancy unless disease-free for at least 5 years, with specified exceptions
- Active gastrointestinal disease or prior surgery affecting oral clofarabine absorption
- Recent nephrotoxic drug treatment within 2 weeks before study drug unless GFR > 30 at two time points
- Positive HIV test
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive intravenous clofarabine in a dose-escalation regimen to treat urothelial carcinoma and assess safety and effectiveness.
1 visit per cycle (in-person)
Follow-up
Duration - Up to 90 days after last dose
Participants are monitored for safety and tolerability for up to 90 days after the last dose of study drug.
Approximately 3 visits (in-person)
Trial Site Locations
Total: 1 location
1
Department of Urology, Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
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Research Team
E
Ekaterina Laukhtina Dr., Medical Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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