Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma

• Status: Terminated
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as temozolomide and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Rituximab may help chemotherapy kill more cancer cells by making cancer cells more sensitive to the drugs. Giving rituximab together with temozolomide and methylprednisolone may be an effective treatment for primary CNS non-Hodgkin's lymphoma.

PURPOSE: This phase II trial is studying how well giving rituximab together with temozolomide and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkin's lymphoma.

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

Details

• Lead Sponsor: North American Brain Tumor Consortium; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary CNS non-Hodgkin's lymphoma by brain biopsy, positive cerebrospinal fluid cytology, or vitrectomy

• Recurrent disease

• Measurable disease, define as bi-dimensionally measurable lesions with clearly defined margins by brain MRI or CT scan

• Radiographical evidence of tumor progression by MRI or CT scan

• Steroid therapy must be stable for 5 days prior to scan

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 8 weeks

Hematopoietic

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 10 g/dL (transfusion allowed)

Hepatic

• SGOT < 2 times upper limit of normal (ULN)

• Bilirubin < 2 times ULN

• No active or latent hepatitis B infection

Renal

• Creatinine < 1.5 mg/dL OR

• Creatinine clearance ≥ 60 mL/min

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No uncontrolled significant medical illness that would preclude study treatment

• No active infection

• No active HIV infection

• No concurrent disease that would dangerously alter drug metabolism or obscure toxicity

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 7 days since prior interferon or thalidomide

• No concurrent prophylactic filgrastim (G-CSF)

• No concurrent immunotherapy

Chemotherapy

• No prior temozolomide

• At least 14 days since prior methotrexate

• At least 21 days since prior procarbazine

• At least 42 days since prior nitrosoureas

• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics

• At least 7 days since prior tamoxifen

• No concurrent hormonal therapy

Radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• Recovered from all prior therapy

• At least 28 days since prior investigational agents

• At least 28 days since other prior cytotoxic therapy

• At least 7 days since other prior non-cytotoxic agents (e.g., tretinoin) (radiosenitizers allowed)

• No other concurrent investigational drugs