Status:
COMPLETED
Methotrexate, Cyclophosphamide, and Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Dexamethasone and Cytarabine in Treating Patients With Primary CNS Lymphoma
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, etoposide phosphate, dexamethasone, and cytarabine, work in different ways to stop cancer cells from dividing so they sto...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity and efficacy of methotrexate, cyclophosphamide, and etoposide phosphate administered in conjunction with osmotic blood-brain barrier disruption and dexam...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed intermediate- or high-grade primary CNS lymphoma by brain biopsy or cerebrospinal fluid or vitrectomy analysis
- No more than 90 days since diagnosis
- No systemic lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- PATIENT CHARACTERISTICS:
- Age
- 16 to 75
- Performance status
- ECOG 0-3 OR
- Karnofsky 40-100%
- Life expectancy
- Not specified
- Hematopoietic
- Hematocrit at least 25% (transfusion allowed)
- WBC at least 2,500/mm\^3
- Absolute granulocyte count at least 1,200/mm\^3
- Platelet count at least 100,000/mm\^3 OR at least lower limit of normal (transfusion independent)
- Hepatic
- Bilirubin no greater than 2.0 times upper limit of normal
- Renal
- Creatinine clearance at least 30 mL/min
- Cardiovascular
- Adequate cardiac function to tolerate general anesthesia
- Pulmonary
- Adequate pulmonary function to tolerate general anesthesia
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 2 months before and during study participation
- No other uncontrolled clinically significant confounding medical condition within the past 30 days
- No known allergy to study agents
- HIV negative
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- Single-agent methotrexate administered within the past 14 days allowed
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior cranial or spinal radiotherapy
- Surgery
- Prior surgery or biopsy allowed
Exclusion
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00074178
Start Date
January 1 2000
End Date
July 1 2006
Last Update
April 21 2017
Active Locations (1)
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1
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States, 97239-3098