Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01399372 : Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
DISEASE CHARACTERISTICS:

- B-cell non-Hodgkin lymphoma (NHL) involving the brain, as demonstrated by contrasted
MRI and histologic confirmation by one of the following within 6 weeks prior to
registration:

- A positive cerebral spinal fluid (CSF) cytology for lymphoma or a monoclonal
lymphocyte population as defined by cell surface markers

- A biopsy of the vitreous or uvea demonstrating NHL

- Brain biopsy

- Patients in whom the type of lymphoma could not be determined or is unknown
(e.g., not enough tissue for further analysis) are assumed to have a B-cell
lymphoma and are eligible

- Patient must agree to submit tissue (i.e., the original H/E-stained slides and
immunohistochemistry studies) for central pathology review post-registration

- No evidence of systemic NHL as demonstrated by a CT scan of the chest, abdomen, and
pelvis within 6 weeks prior to registration

- Bone marrow biopsy is not required for registration but must be obtained prior
to start of treatment

PATIENT CHARACTERISTICS:

- History and physical examination within 6 weeks of registration

- Karnofsky performance status (KPS) equal to 50% or higher, with the following
exception:

- KPS 30% to 50% are eligible if the reason for the poor performance status is
neurologic deficit from primary central nervous system (CNS) lymphoma

- Patients with KPS 30% to 50% due to reasons other than primary CNS lymphoma
are ineligible

- Patients with KPS under 30% for any reason are ineligible

- Absolute neutrophil count (ANC) ? 1,500/mm³

- Platelet count ? 100,000/mm³

- Hemoglobin (Hgb) ? 8.0 g/dL (transfusion or other intervention to achieve Hgb ? 8.0
g/dL is acceptable)

- Bilirubin < 2.0 mg/dL

- Aspartate aminotransferase (AST) < 2.5 times upper limit of normal

- Serum creatinine < 1.5 mg/dL

- Calculated creatinine clearance (CrCl) > 50 cc/min (CrCl from a 24-hour urine
collection may also be used)

- Women of childbearing potential and male participants must agree to practice adequate
contraception during therapy

- Patient must be able to swallow pills

- Patient must have documentation of negative HIV-1 testing within 6 weeks prior to
study registration

- No prior invasive malignancy (except non-melanomatous skin cancer) unless disease
free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral
cavity, or cervix are all permissible)

- No severe, active co-morbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within 30 days before
registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Laboratory tests for liver function and coagulation parameters are not
required for entry into this protocol

- Known pre-existing immunodeficiency as seen in organ transplant recipient

- No prior allergic reaction to any of the study drugs involved in this protocol

PRIOR CONCURRENT THERAPY:

- No prior treatment with chemotherapy or radiotherapy for lymphoma or chronic
lymphocytic leukemia

- Prior chemotherapy for a different cancer is allowable

- No prior cranial irradiation

- No concurrent intensity-modulated radiotherapy
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01399372      |      Link to official Clinicaltrials.gov listing
Locations
Phoenix, Arizona
Facility: Saint Joseph's Hospital and Medical Center
Investigator: David G. Brachman
Contact: David G. Brachman Phone: 877-602-4111
Email not avaialable

Scottsdale, Arizona
Facility: Arizona Oncology Services Foundation
Investigator: David G. Brachman
Contact: David G. Brachman Phone: 877-602-4111
Email not avaialable

Fresno, California
Facility: Fresno Cancer Center
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 626-564-3455
Email not avaialable

Rancho Cordova, California
Facility: Kaiser Permanente-Rancho Cordova Cancer Center
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 626-564-3455
Email not avaialable

Rohnert Park, California
Facility: Rohnert Park Cancer Center
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 626-564-3455
Email not avaialable

Roseville, California
Facility: The Permanente Medical Group-Roseville Radiation Oncology
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 626-564-3455
Email not avaialable

Sacramento, California
Facility: South Sacramento Cancer Center
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 626-564-3455
Email not avaialable

Santa Clara, California
Facility: Kaiser Permanente Medical Center - Santa Clara
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 626-564-3455
Email not avaialable

South San Francisco, California
Facility: Kaiser Permanente Cancer Treatment Center
Investigator: Samantha A. Seaward
Contact: Samantha A. Seaward Phone: 626-564-3455
Email not avaialable

Tampa, Florida
Facility: Moffitt Cancer Center
Investigator: Peter A. Forsyth
Contact: Peter A. Forsyth Phone: 800-456-7121
Click HERE to send email to this center

Boise, Idaho
Facility: Saint Alphonsus Cancer Care Center-Boise
Investigator: Samir Narayan
Contact: Samir Narayan Phone: 734-712-4673
Email not avaialable

Chicago, Illinois
Facility: Northwestern University
Investigator: Jeffrey J. Raizer
Contact: Jeffrey J. Raizer Phone: 312-695-1301
Click HERE to send email to this center

Chicago, Illinois
Facility: Rush University Medical Center
Investigator: Reem Karmali
Contact: Reem Karmali Phone: 312-942-5498
Click HERE to send email to this center

Maywood, Illinois
Facility: Loyola University Medical Center
Investigator: Edward Melian
Contact: Edward Melian Phone: 708-226-4357
Email not avaialable

Warrenville, Illinois
Facility: Cadence Cancer Center in Warrenville
Investigator: Vinai Gondi
Contact: Vinai Gondi Phone: 630-352-5300
Email not avaialable

Scarborough, Maine
Facility: Maine Medical Center- Scarborough Campus
Investigator: Ian J. Bristol
Contact: Ian J. Bristol Phone: 207-396-8090
Click HERE to send email to this center

Baltimore, Maryland
Facility: University of Maryland/Greenebaum Cancer Center
Investigator: Young Kwok
Contact: Young Kwok Phone: 800-888-8823
Email not avaialable

Ann Arbor, Michigan
Facility: Saint Joseph Mercy Hospital
Investigator: Samir Narayan
Contact: Samir Narayan Phone: 734-712-4673
Email not avaialable

Kalamazoo, Michigan
Facility: West Michigan Cancer Center
Investigator: Raymond S. Lord
Contact: Raymond S. Lord Phone: 269-373-7458
Email not avaialable

Las Vegas, Nevada
Facility: Nevada Cancer Research Foundation CCOP
Investigator: John A. Ellerton
Contact: John A. Ellerton Phone: 702-384-0013
Email not avaialable

Lebanon, New Hampshire
Facility: Dartmouth Hitchcock Medical Center
Investigator: Alan C. Hartford
Contact: Alan C. Hartford Phone: 800-639-6918
Click HERE to send email to this center

New York, New York
Facility: Memorial Sloan-Kettering Cancer Center
Investigator: Antonio M. Omuro
Contact: Antonio M. Omuro Phone: 212-639-7202
Email not avaialable

Rochester, New York
Facility: University of Rochester
Investigator: Yuhchyau Chen
Contact: Yuhchyau Chen Phone: 585-275-5830
Email not avaialable

Cincinnati, Ohio
Facility: University of Cincinnati
Investigator: Kevin P. Redmond
Contact: Kevin P. Redmond Phone: 513-558-4553
Click HERE to send email to this center

Cleveland, Ohio
Facility: Case Western Reserve University
Investigator: Paolo F. Caimi
Contact: Paolo F. Caimi Phone: 800-641-2422
Email not avaialable

Cleveland, Ohio
Facility: Cleveland Clinic Foundation
Investigator: Erin S. Murphy
Contact: Erin S. Murphy Phone: 866-223-8100
Email not avaialable

West Chester, Ohio
Facility: University Pointe
Investigator: Kevin P. Redmond
Contact: Kevin P. Redmond Phone: 513-558-4553
Click HERE to send email to this center

Danville, Pennsylvania
Facility: Geisinger Medical Center
Investigator: Thomas J. Gergel
Contact: Thomas J. Gergel Phone: 570-271-5251
Email not avaialable

Philadelphia, Pennsylvania
Facility: American College of Radiology Imaging Network
Investigator: Antonio M. Omuro
Contact: Antonio M. Omuro Phone: 212-639-7523
Click HERE to send email to this center

Philadelphia, Pennsylvania
Facility: Thomas Jefferson University Hospital
Investigator: Jon Glass
Contact: Jon Glass Phone: 215-955-6084
Email not avaialable

Wilkes-Barre, Pennsylvania
Facility: Geisinger Wyoming Valley/Henry Cancer Center
Investigator: Thomas J. Gergel
Contact: Thomas J. Gergel Phone: 570-271-5251
Email not avaialable

Houston, Texas
Facility: M D Anderson Cancer Center CCOP Research Base
Investigator: Ivo W. Tremont
Contact: Ivo W. Tremont Phone: 504-340-6976
Email not avaialable

Milwaukee, Wisconsin
Facility: Froedtert and the Medical College of Wisconsin
Investigator: Joseph A. Bovi
Contact: Joseph A. Bovi Phone: 414-805-4380
Email not avaialable

Waukesha, Wisconsin
Facility: Waukesha Memorial Hospital
Investigator: Wingate F. Clapper
Contact: Wingate F. Clapper Phone: 262-928-7632
Click HERE to send email to this center




Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2018 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740


Website Design By
World Wide Websites