Status:
COMPLETED
Methotrexate, Procarbazine, Lomustine, 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, procarbazine, lomustine, dexamethasone, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. ...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity and efficacy of methotrexate, procarbazine, lomustine, dexamethasone, and cytarabine in patients with primary CNS lymphoma. Secondary * Determine the a...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed intermediate- or high-grade primary CNS lymphoma documented by brain biopsy or cerebrospinal fluid or vitrectomy analysis
- Diagnosed within the past 90 days
- 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
- WBC at least 2,500/mm\^3
- Hematocrit at least 25% (transfusion 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 (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 :
October 1 2000
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00074191
Start Date
January 1 2000
End Date
October 1 2000
Last Update
April 21 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States, 97239-3098