Methotrexate, Cyclophosphamide, and Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Dexamethasone and Cytarabine in Treating Patients With Primary CNS Lymphoma

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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 stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain. Giving methotrexate, cyclophosphamide, and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of giving methotrexate, cyclophosphamide, and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine in treating patients who have primary CNS lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoposide; Etoposide phosphate; Methotrexate

Criteria

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