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

Alternate Title

Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Any age	NCI	MSKCC-01146 NCT00059956

Objectives

1. Determine the efficacy of induction immunochemotherapy comprising rituximab, methotrexate, procarbazine, and vincristine followed by reduced-dose radiotherapy and consolidation cytarabine in patients with newly diagnosed primary central nervous system lymphoma.
2. Determine the 2-year and overall disease-free survival of patients treated with this regimen.
3. Determine the progression-free and overall survival of patients treated with this regimen.
4. Determine the acute treatment-related toxicity and safety of this regimen in these patients.
5. Determine the initial response rate of patients treated with immunochemotherapy.
6. Determine the relapse rate after complete response in patients treated with this regimen.
7. Determine the neuro-cognitive outcome in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed primary non-Hodgkin's lymphoma by brain biopsy
  • Patients who have an inconclusive biopsy or who are not a candidate for biopsy are eligible provided they have a typical cranial MRI or CT scan* AND meet at least 1 of the following criteria:
    • Positive cerebrospinal fluid cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers
    • Biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma

   [Note: *Typical MRI or CT scan is defined as the presence of hypo-, iso-, or hyperdense parenchymal contrast-enhancing (usually homogeneously) mass lesion(s)]




• HIV-1 negative



• Normal or negative pretreatment systemic evaluation including the following examinations:
  • Bone marrow aspirate and biopsy
  • CT scans of the chest, abdomen, and pelvis

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for CNS lymphoma

Endocrine therapy

• Not specified

Radiotherapy

• No prior cranial radiotherapy

Surgery

• Not specified

Other

• No citrus fruit, citrus fruit juices, or ascorbic acid supplements during and for 72 hours after methotrexate administration

Patient Characteristics:

Age

• Any age

Performance status

• Not specified

Life expectancy

• At least 8 weeks

Hematopoietic

• WBC at least 4,000/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• SGOT no greater than 2 times upper limit of normal

Renal

• Creatinine no greater than 1.5 mg/dL

  OR

• Creatinine clearance at least 50 mL/min

Other

• Not pregnant
• Fertile patients must use effective contraception during and for 6 months after study participation
• No other active primary malignancy except basal cell skin cancer or carcinoma in situ of the cervix
• No pre-existing immunodeficiency (e.g., renal transplantation recipient)
• Must maintain a tyramine-free diet (i.e., free of alcohol and certain cheeses) during procarbazine administration

Expected Enrollment

A total of 15-30 patients will be accrued for this study within 3 years.

Outcomes

Treatment related toxicity assessed by NCI CTC
Disease-free survival at 1 year

Response rate assessed radiographically every 2 months
Overall survival
Progression-free survival

Outline

This is a multicenter, pilot study.

• Induction immunochemotherapy: Patients receive rituximab IV over 5 hours on day 1 and methotrexate IV over 2 hours and vincristine IV over several minutes on day 2. Patients also receive oral procarbazine on days 2-8 during courses 1, 3, and 5. Treatment repeats every 2 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response after 5 courses may receive an additional 2 courses.



• Radiotherapy: Beginning 3-5 weeks after completion of induction immunochemotherapy, patients undergo radiotherapy daily 5 days a week for 3-6 weeks.



• Consolidation chemotherapy: Patients receive cytarabine IV over 3 hours on days 1 and 2. Treatment repeats every 28 days for a total of 2 courses.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Lauren Abrey, MD, Protocol chair		Ph: 212-639-5122; 800-525-2225 Email: abreyl@mskcc.org

Registry Information
Official Title		A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients with Newly Diagnosed PCNSL
Trial Start Date		2002-08-28
Registered in ClinicalTrials.gov		NCT00059956
Date Submitted to PDQ		2003-03-12
Information Last Verified		2005-08-19
NCI Grant/Contract Number		P30-CA08748

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