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Rituximab and Combination Che...

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

Last Updated: 2023-07-03

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-23

Study Completion Date

2015-07-31

Brief Summary

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RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.

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Detailed Description

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OBJECTIVES:

Primary

* Determine the complete response rate.

Secondary

* 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.

Conditions

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Lymphoma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab + standard chemotherapy

Rituximab + high dose methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine. Patients with meningeal involvement will receive additional methotrexate and leucovorin.

Group Type EXPERIMENTAL

Rituximab

Intervention Type BIOLOGICAL

Rituximab is administered intravenously. The initial rate is 50 mg/hr for the first hour. If no toxicity is seen, the rate may be escalated gradually in 50 mg/hour increments at 30-minute intervals to a maximum of 300 mg/hr. If the first dose is well tolerated, the initial rate for subsequent dose is 100 mg/hr, increased gradually in 100 mg/hr increments at 30-minute intervals, not to exceed 400 mg/hr.

Cytarabine

Intervention Type DRUG

3 g/m2/day in 500 cc D5W IV over 2 hrs. x 2 doses 24hrs. apart, Weeks 11, 14

Dexamethasone

Intervention Type DRUG

16mg (week 1) PO daily Weeks 1, 2, 3, 4, 5, 6 Taper by 4 mg/wk, weeks 2, 3, by 2 mg/wk week 4, 5, 6

Leucovorin

Intervention Type DRUG

25 mg PO/IV every 6 hrs. x 12 doses, Weeks 1, 3, 5, 7, 9 For patients with meningeal involvement additionally 10 mg PO every 12 hrs. x 8 doses, Weeks 2, 4, 6, 8, 10

Methotrexate

Intervention Type DRUG

3.5 g/m2In 500 cc D5W + 25 mEq NaHCO3 IV over 2 hours, Weeks 1, 3, 5, 7, 9

For patients with meningeal involvement additionally:

12 mg Intrathecally, in preservative-free sterile .9NS Weeks 2, 4, 6, 8, 10 Via Ommaya or lumbar puncture

Procarbazine

Intervention Type DRUG

100 mg/m2 PO daily x 7 days Weeks 1, 5, 9

Vincristine

Intervention Type DRUG

1.4 mg/m2 IV push, Weeks 1, 3, 5, 7, 9 2m2 (2.8 mg) dose cap

Interventions

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Rituximab

Intervention Type BIOLOGICAL

Cytarabine

3 g/m2/day in 500 cc D5W IV over 2 hrs. x 2 doses 24hrs. apart, Weeks 11, 14

Intervention Type DRUG

Dexamethasone

16mg (week 1) PO daily Weeks 1, 2, 3, 4, 5, 6 Taper by 4 mg/wk, weeks 2, 3, by 2 mg/wk week 4, 5, 6

Intervention Type DRUG

Leucovorin

25 mg PO/IV every 6 hrs. x 12 doses, Weeks 1, 3, 5, 7, 9 For patients with meningeal involvement additionally 10 mg PO every 12 hrs. x 8 doses, Weeks 2, 4, 6, 8, 10

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

Procarbazine

100 mg/m2 PO daily x 7 days Weeks 1, 5, 9

Intervention Type DRUG

Vincristine

1.4 mg/m2 IV push, Weeks 1, 3, 5, 7, 9 2m2 (2.8 mg) dose cap

Intervention Type DRUG

Other Intervention Names

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Rituxan Cytosar-U Ara-C Arabinosylcytosine Decadron Dexasone Diodex Hexadrol Maxidex dexamethasone sodium phosphate dexamethasone acetate leucovorin calcium Otrexup Rasuvo Rheumatrex Trexall Amethopterin Methotrexate Sodium MTX Matulane Procarbazine hydrochloride Vincristine Sulfate Oncovin Vincasar LCR VCR

Eligibility Criteria

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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 disease
* If an excisional, rather than a needle biopsy was done, measurable disease must be present on a postoperative scan (not a PET-CT scan)
* 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
* Negative pregnancy test
* Fertile patients must use effective contraception

Exclusion Criteria

* Pregnant or nursing
* HIV-1 positivity
* Other malignancy within the past 5 years except basal cell skin cancer or any carcinoma in situ
* Pre-existing immunodeficiency
* Hepatitis B surface antigen positivity
* Systemic lymphoma (as determined by pre-registration CT scans and physical examination)
* Prior chemotherapy or radiotherapy for primary central nervous system lymphoma
* Prior organ or bone marrow transplantation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lode J. Swinnen, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Deborah T. Blumenthal, MD

Role: STUDY_CHAIR

University of Utah

Locations

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Stanford Cancer Center

Stanford, California, United States

Site Status

University of Florida Shands Cancer Center

Gainesville, Florida, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Site Status

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

Site Status

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Hospital District Sixth of Harper County

Anthony, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status