Status:
TERMINATED
Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Drug/Agent Toxicity by Tissue/Organ
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy,...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of rituximab, carboplatin, cyclophosphamide, etoposide or etoposide phosphate and cytarabine administered in conjunction with osmotic blood-brain barrier...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Signed informed consent form in accordance with institutional guidelines
- Histologically or cytologically confirmed primary CNS lymphoma documented by brain biopsy or cerebrospinal fluid or vitrectomy analysis
- CD20 positive disease
- Progressive or relapsed disease during or after completion of prior methotrexate-based chemotherapy
- Aged 18 months to 75 years
- Performance status ECOG 0-3 OR Karnofsky 30-100%
- Hematocrit at least 25% (transfusion or epoetin alfa allowed)
- Absolute granulocyte count at least 1,200/mm\^3
- Platelet count at least 100,000/mm\^3 OR at least lower limit of normal
- Bilirubin no greater than 2.0 times upper limit of normal
- Creatinine less than 1.8 mg/dL
- Calculated Creatinine clearance (CrCl) at least 50 mL/min
- Adequate cardiac function to tolerate general anesthesia
- Adequate pulmonary function to tolerate general anesthesia
- Available for follow-up for 1 year post therapy
- Fertile patients must use effective contraception for a minimum of 2 months before and during study participation
- EXCLUSION CRITERIA:
- Radiographic signs of intra-cranial herniation and/or spinal block
- HIV positive
- Systemic lymphoma
- Positive serum HCG, pregnant or lactating
- Allergy to study agents
- Hepatitis B or hepatitis C positive
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00074165
Start Date
January 1 2003
End Date
December 1 2010
Last Update
July 6 2023
Active Locations (2)
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1
Good Samaritan Hospital Cancer Treatment Center, Hatton Institute
Cincinnati, Ohio, United States, 45220
2
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098