Status:
COMPLETED
A Phase I/II Study to Investigate the Use of VORAXAZE™ As Intended Intervention in Patients with CNSL
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
CNS Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I-II trial is intented to demonstrate tolerability (i.e. absence of severe non-hematological toxicity) and efficacy of intended intervention with repeated doses of Voraxaze, in addition to ...
Detailed Description
MTX is used either alone or as part of a combined chemotherapy protocol either in standard or high doses in the treatment of a range of cancers and other diseases. Dose escalation will be performed u...
Eligibility Criteria
Inclusion
- Primary or secondary CNSL (PCNSL or SCNSL) confirmed by histology or cytology.
- Renal insufficiency defined as a glomerular filtration rate (GFR, assessed by CKD-EPI or MDRD equation) of 40-80 mL/min or patients with a GFR \>80mL/min who have experienced renal failure, defined as doubling of the serum creatinine compared to the baseline value during a previous HD-MTX treatment.
- Age ≥ 18 years (male or female).
- Life expectancy \>3 months.
- Adequate organ function (i.e., bone marrow, liver, lungs) allowing intensive chemotherapy with MTX.
- Adequate clinical pathology values:
- Absolute neutrophil count ≥1.0 x 109/L, hemoglobin ≥9mg/dL (transfusion allowed), platelets ≥100 x 109/L.
- Total bilirubin ≤1.5x the upper limit of normal except for patients with known Gilbert syndrome.
- Alanine amino-transferase (ALT) and aspartate amino-transferase (AST) ≤2x the upper limit of normal.
- Alkaline phosphatase ≤2x the upper limit of normal.
- Prothrombin time within the normal range for the institution.
- Signed informed consent by the patient or legal representative prior to start of any study specific procedure.
- Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study in such a manner that the risk of pregnancy is minimized. Acceptable contraceptives include intra-uterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
Exclusion
- Ongoing or expected need for therapy with drugs interfering with MTX-clearance (i.e., beta-lactam antibiotics, NSAIDs, probenicid, salicylates, sulphonamides) or other nephrotoxic drugs.
- Prior brain radiotherapy within 28 days of first dose of the study drug.
- Concurrent illness interfering with hydration (i.e., relevant congestive heart failure, SIADH syndrome).
- Relevant third space (i.e., pleural effusion, ascites, extended edema) precluding HD-MTX treatment.
- Obesity (body mass index \>30 kg/m2).
- Uncontrolled diabetes.
- Active hepatitis.
- HIV-infection.
- Pregnant or lactating woman.
- Participation in any other clinical trial either 1 month prior to or during this study.
- Previous intolerance to any of the drugs used in this study (i.e., MTX, LV)
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04841434
Start Date
June 1 2021
End Date
December 1 2024
Last Update
January 6 2025
Active Locations (1)
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1
Charité Campus Benjamin Franklin (CBF)
Berlin, Germany, 12200