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Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma

Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma



- Determine the complete response rate.


- Determine the progression-free survival of these patients.

- Determine the proportion of progression-free and overall survival in these patients.

- Determine rituximab cerebrospinal fluid pharmacokinetics (only in patients requiring
intrathecal chemotherapy).

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.

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

Inclusion Criteria


- 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

- 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


- 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


- No prior chemotherapy or radiotherapy for primary central nervous system lymphoma

- No prior organ or bone marrow transplantation

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate at the end of study treatment

Safety Issue:


Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • Lymphoma



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Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
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HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
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Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
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Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
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University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Wesley Medical Center Wichita, Kansas  67214
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Southwest Medical Center Liberal, Kansas  67901
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
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