Status:
COMPLETED
Methotrexate, Glucarpidase, and Leucovorin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
Lead Sponsor:
University College, London
Collaborating Sponsors:
Cancer Research UK
Conditions:
Chemotherapeutic Agent Toxicity
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as methotrexate and leucovorin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Gl...
Detailed Description
OBJECTIVES: Primary * To determine the dose-limiting toxicity of methotrexate (MTX) when given in combination with glucarpidase in patients with newly diagnosed primary CNS lymphoma (PCNSL). * To de...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed primary CNS lymphoma (PCNSL)
- Previously untreated disease
- Diffuse large B-cell lymphoma histology
- Must be clinically eligible to receive standard 3 g/m² methotrexate if outside trial
- No clinically significant effusions or edema
- PATIENT CHARACTERISTICS:
- Inclusion criteria:
- ECOG performance status 0-3
- Neutrophils ≥ 1 x 10\^9/L
- Platelet count ≥ 100 x 10\^9/L
- Bilirubin \< 1.5 times upper limit of normal
- Glomerular filtration rate (initially measured by EDTA/isotope method) ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- Exclusion criteria:
- HIV positivity
- Dementia or neurological dysfunction not considered to be due to the PCNSL
- Other serious or uncontrolled medical conditions
- Prior malignancy, except adequately treated nonmelanoma skin cancer or carcinoma in situ
- PRIOR CONCURRENT THERAPY:
- No prior cytotoxic chemotherapy
- No concurrent prophylactic antibiotics
- No concurrent co-trimoxazole
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00727831
Start Date
July 1 2008
End Date
July 1 2011
Last Update
January 27 2014
Active Locations (2)
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1
Leeds General Infirmary
Leeds, England, United Kingdom, LS1 3EX
2
Torbay Hospital
Torquay, England, United Kingdom, TQ2 7AA