Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma

Basic Trial Information

Objectives

Primary

1. Determine the complete response rate.

Secondary

1. Determine the progression-free survival of these patients.
2. Determine the proportion of progression-free and overall survival in these patients.
3. Determine rituximab cerebrospinal fluid pharmacokinetics (only in patients requiring intrathecal chemotherapy).

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-Hodgkin's lymphoma by brain biopsy

• Patients with inconclusive biopsy or patients who are not candidates for biopsy must have typical CT scan or MRI of the brain AND meet ≥ 1 of the following criteria:
  • Positive cerebrospinal fluid cytology for lymphoma OR a monoclonal lymphoid population as defined by cell surface markers or immunoglobulin gene rearrangement studies
  • Biopsy-proven involvement of the vitreous or uvea if cells are apparent in the posterior chamber or vitreous by ophthalmological examination

• Bideminsionally measurable disease, defined as contrast-enhancing tumor ≥ 1 cm by pretreatment MRI/CT scan
  • Meningeal or vitreous involvement constitutes evaluable but not measurable disease
  • If an excisional, rather than a needle biopsy was done, measurable disease must be present on a postoperative scan
  • PET-CT scan not allowed

• No systemic lymphoma (as determined by pre-registration CT scans and physical examination)

Prior/Concurrent Therapy:

• No prior chemotherapy or radiotherapy for primary central nervous system lymphoma
• No prior organ or bone marrow transplantation

Patient Characteristics:

• ECOG performance status 0-3
• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ upper limit of normal (ULN)
• SGOT ≤ 2.0 times ULN
• Creatinine clearance ≥ 50 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No HIV-1 positivity
• No other malignancy within the past 5 years except basal cell skin cancer or any carcinoma in situ
• No pre-existing immunodeficiency
• No hepatitis B surface antigen positivity

Expected Enrollment

A total of 43 patients will be accrued for this study.

Outcomes

Complete response rate at the end of study treatment

Progression-free survival
Proportion progression free
Survival

Outline

This is a multicenter study.

Patients receive rituximab IV 3 times weekly in weeks 1-4; high-dose methotrexate IV over 2 hours in weeks 1, 3, 5, and 9; oral or IV leucovorin calcium every 6 hours for 12 doses beginning 24 hours after the start of methotrexate in weeks 1, 3, 5, and 9; vincristine IV in weeks 1, 3, 5, 7, and 9; oral procarbazine hydrochloride daily on days 1-7 in weeks 1, 5, and 9; oral dexamethasone daily in weeks 1-6; and cytarabine IV over 2 hours twice weekly in weeks 11 and 14.

Patients with positive cerebrospinal fluid also receive methotrexate intrathecally and oral leucovorin calcium every 12 hours for 8 doses beginning 24 hours after the start of methotrexate in weeks 2, 4, 6, 8, and 10.

After completion of study treatment, patients are followed periodically for 5 years.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Lode Swinnen, MD, Protocol chair		Ph: 410-614-3698
Deborah Blumenthal, MD, Protocol co-chair		Ph: 801-585-0211; 877-585-0303 Email: deborah.blumenthal@hsc.utah.edu

Registry Information
Official Title		Phase II Study of Rituximab Given in Conjunction with Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma
Trial Start Date		2006-12-21
Trial Completion Date		2011-10-15 (estimated)
Registered in ClinicalTrials.gov		NCT00335140
Date Submitted to PDQ		2006-03-07
Information Last Verified		2010-02-25
NCI Grant/Contract Number		CA21115

Back to Top