Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Last Modified: 4/16/2009 First Published: 8/24/2003
Alternate Title
Basic Trial Information
Trial Description
Purpose
Eligibility
Treatment/Intervention
Trial Contact Information
Registry Information
Alternate Title
Phase I/II Study of Chemotherapy Comprising Methotrexate, Rituximab, and Temozolomide Before Radiotherapy and Temozolomide After Radiotherapy in Patients With Primary Central Nervous System Lymphoma
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II, Phase I | Treatment | Active | 18 and over | RTOG-0227
NCT00068250 |
Trial Description Purpose: Drugs used in chemotherapy such as methotrexate and temozolomide use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining methotrexate, temozolomide, and rituximab with radiation therapy may kill more cancer cells.
This phase I/II trial is studying the side effects and best dose of temozolomide when given together with methotrexate and rituximab followed by radiation therapy and to see how well they work in treating patients with primary central nervous system lymphoma. Eligibility: Eligibility criteria include the following: Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Treatment/Intervention: Patients will receive an infusion of rituximab followed 3 days later with a 4-hour infusion of methotrexate. Methotrexate will be repeated in weeks 3, 5, 7, and 9. Patients will also receive temozolomide by mouth once a day for 5 days in weeks 4 and 8. They will then undergo radiation therapy to the brain 5 days a week in weeks 11-13. Beginning in week 14, patients will receive temozolomide by mouth once a day for 5 days. Temozolomide may be repeated every 4 weeks for up to 10 courses. Quality of life will be assessed periodically. Patients will be evaluated every 3 months for 2 years, every 6 months for 3 years, and once a year thereafter.
Important: For more details about this trial, refer to the Health Professional version 6 of the trial summary. If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on
NCI's Web site 7.
Trial Contact Information
Trial Lead Organizations Radiation Therapy Oncology Group  | | | | Jon Glass, MD, Protocol chair | | | |
Trial Sites
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| U.S.A. |
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| Florida |
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Jacksonville |
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| | | | | | | | | Baptist Cancer Institute - Jacksonville |
| | | Clinical Trials Office - Baptist Cancer Institute - Jacksonville | |
| | | Integrated Community Oncology Network at Southside Cancer Center |
| | | Douglas Johnson, MD | |
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Jacksonville Beach |
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| | | Integrated Community Oncology Network |
| | | Douglas Johnson, MD | |
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Jascksonville |
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| | | Baptist Medical Center South |
| | | Douglas Johnson, MD | |
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Orange Park |
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| | | Integrated Community Oncology Network - Orange Park |
| | | Douglas Johnson, MD | |
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Palatka |
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| | | Florida Cancer Center - Palatka |
| | | Douglas Johnson, MD | |
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Saint Augustine |
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| | | Flagler Cancer Center |
| | | Douglas Johnson, MD | |
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| Illinois |
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Urbana |
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| | | | CCOP - Carle Cancer Center |
| | | Clinical Trials Office - CCOP - Carle Cancer Center | |
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| Missouri |
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Saint Louis |
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| | | | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
| | | David Mansur | | Ph: | 314-747-7222 | | 800-600-3606 |
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| New Jersey |
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Edison |
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| | | | John F. Kennedy Medical Center |
| | | Mark Macher, MD | |
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| Ohio |
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Cleveland |
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| | | | Cleveland Clinic Taussig Cancer Center |
| | | Clinical Trials Office - Cleveland Clinic Taussig Cancer Center | |
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| Oregon |
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Gresham |
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| | | | Legacy Mount Hood Medical Center |
| | | Clinical Trials Office - Legacy Mount Hood Medical Center | |
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Milwaukie |
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| | | Providence Milwaukie Hospital |
| | | Keith Lanier, MD | |
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Portland |
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| | | CCOP - Columbia River Oncology Program |
| | | Keith Lanier, MD | |
| | | Legacy Emanuel Hospital and Health Center and Children's Hospital |
| | | Clinical Trials Office - Legacy Emanuel Hospital and Health Center and Children's Hospital | |
| | | Legacy Good Samaritan Hospital & Comprehensive Cancer Center |
| | | Clinical Trials Office - Legacy Good Samaritan Hospital & Comprehensive Cancer Center | |
| | | Providence Cancer Center at Providence Portland Medical Center |
| | | Clinical Trials Office - Providence Cancer Center at Providence Portland Medical Center | |
| | | Providence St. Vincent Medical Center |
| | | Clinical Trials Office - Providence St. Vincent Medical Center | |
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Tualatin |
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| | | Legacy Meridian Park Hospital |
| | | Clinical Trials Office - Legacy Meridian Park Hospital | |
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| Pennsylvania |
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Philadelphia |
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| | | | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia |
| | | Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
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| South Carolina |
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Charleston |
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| | | | Hollings Cancer Center at Medical University of South Carolina |
| | | Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina | |
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Spartanburg |
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| | | CCOP - Upstate Carolina |
| | | Clinical Trials Office - CCOP - Upstate Carolina | |
| | | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center |
| | | Clinical Trials Office - Gibbs Regional Cancer Center | |
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| Utah |
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Murray |
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| | | | Jon and Karen Huntsman Cancer Center at Intermountain Medical Center |
| | | R. Jeffrey Lee, MD | |
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Provo |
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| | | Utah Valley Regional Medical Center - Provo |
| | | Clinical Trials Office - Utah Valley Regional Medical Center - Provo | |
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| Washington |
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Vancouver |
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| | | | Southwest Washington Medical Center Cancer Center |
| | | Keith Lanier, MD | |
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| Wisconsin |
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Menomonee Falls |
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| | | | Community Memorial Hospital Cancer Care Center |
| | | Christopher Schultz, MD | |
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Milwaukee |
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| | | Medical College of Wisconsin Cancer Center |
| | | Clinical Trials Office - Medical College of Wisconsin Cancer Center | |
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| Registry Information | | | Official Title | | Phase I/II Study Of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, And Temozolomide And Post -Irradiation Temozolomide For Primary Central Nervous System Lymphoma | | | Trial Start Date | | 2003-07-22 | | | Trial Completion Date | | 2010-03-22 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00068250 8 | | | Date Submitted to PDQ | | 2003-03-25 | | | Information Last Verified | | 2009-04-16 | | | NCI Grant/Contract Number | | CA21661 |
Glossary Terms
cancer (KAN-ser)
A term for
diseases in which abnormal cells divide without control and
can invade nearby tissues. Cancer cells can also spread to
other parts of the body through the blood and lymph
systems. There are several main types of cancer. Carcinoma
is cancer that begins in the skin or in tissues that line
or cover internal organs. Sarcoma is cancer that begins in
bone, cartilage, fat, muscle, blood vessels, or other
connective or supportive tissue. Leukemia is cancer that
starts in blood-forming tissue such as the bone marrow, and
causes large numbers of abnormal blood cells to be produced
and enter the blood. Lymphoma and multiple myeloma are
cancers that begin in the cells of the immune system.
Central nervous system cancers are cancers that begin in
the tissues of the brain and spinal cord.
cell (sel)
The individual unit that makes up the tissues of the body. All living things are made up of one or more cells.
chemotherapy (KEE-moh-THAYR-uh-pee)
Treatment with drugs that kill cancer cells.
dose
The amount of medicine taken, or radiation given, at one time.
drug
Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.
eligibility criteria (EH-lih-jih-BIH-lih-tee kry-TEER-ee-uh)
In clinical trials, requirements that must be met for an individual to be included in a study. These requirements help make sure that patients in a trial are similar to each other in terms of specific factors such as age, type and stage of cancer, general health, and previous treatment. When all participants meet the same eligibility criteria, it gives researchers greater confidence that results of the study are caused by the intervention being tested and not by other factors.
infusion (in-FYOO-zhun)
A method of putting fluids, including drugs, into the bloodstream. Also called intravenous infusion.
lymphoma (lim-FOH-muh)
Cancer that begins in cells of the immune system. There are two basic categories of lymphomas. One kind is Hodgkin lymphoma, which is marked by the presence of a type of cell called the Reed-Sternberg cell. The other category is non-Hodgkin lymphomas, which includes a large, diverse group of cancers of immune system cells. Non-Hodgkin lymphomas can be further divided into cancers that have an indolent (slow-growing) course and those that have an aggressive (fast-growing) course. These subtypes behave and respond to treatment differently. Both Hodgkin and non-Hodgkin lymphomas can occur in children and adults, and prognosis and treatment depend on the stage and the type of cancer.
methotrexate (meh-thuh-TREK-sayt)
A drug used to treat some types of cancer, rheumatoid arthritis, and severe skin conditions, such as psoriasis. Methotrexate stops cells from making DNA and may kill cancer cells. It is a type of antimetabolite. Also called amethopterin, MTX, and Rheumatrex.
monoclonal antibody (MAH-noh-KLOH-nul AN-tee-BAH-dee)
A type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. There are many kinds of monoclonal antibodies. Each monoclonal antibody is made to find one substance. Monoclonal antibodies are being used to treat some types of cancer and are being studied in the treatment of other types. They can be used alone or to carry drugs, toxins, or radioactive materials directly to a tumor.
organ
A part of the body that performs a specific function. For example, the heart is an organ.
phase I/II trial
A trial to study the safety, dosage levels, and response to a new treatment.
primary central nervous system lymphoma (PRY-mayr-ee SEN-trul NER-vus SIS-tem lim-FOH-muh)
Cancer that forms in the lymph tissue of the brain, spinal cord, meninges (outer covering of the brain), or eye (called ocular lymphoma). Also called PCNSL and primary CNS lymphoma.
quality of life
The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on the quality of life. These studies measure aspects of an individual’s sense of well-being and ability to carry out various activities.
radiation therapy (RAY-dee-AY-shun THAYR-uh-pee)
The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.
rituximab (rih-TUK-sih-mab)
A monoclonal antibody used to treat certain types of B-cell non-Hodgkin lymphoma and symptoms of rheumatoid arthritis. Monoclonal antibodies are made in the laboratory and can bind to substances in the body, including cancer cells. Rituximab binds to the protein called CD20, which is found on B-cells, and may kill cancer cells. Also called Rituxan.
side effect
A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.
systemic (sis-TEH-mik)
Affecting the entire body.
temozolomide (teh-moh-ZOH-loh-mide)
A drug that is used to treat certain types of brain tumors in adults and is being studied in the treatment of other types of cancer. It belongs to the family of drugs called alkylating agents. Also called Temodar.
transplantation (tranz-plan-TAY-shun)
A surgical procedure in which tissue or an organ is transferred from one area of a person’s body to another area, or from one person (the donor) to another person (the recipient).
x-ray
A type of high-energy radiation. In low doses, x-rays are used to diagnose diseases by making pictures of the inside of the body. In high doses, x-rays are used to treat cancer.
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Table of Links
| 1 | http://www.cancer.gov/clinicaltrials/learning |
| 2 | http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials |
| 3 | http://www.cancer.gov/clinicaltrials/learning/questions-to-ask-about-participat
ing |
| 4 | http://www.nlm.nih.gov/medlineplus/druginformation.html |
| 5 | http://www.cancer.gov/clinicaltrials/RTOG-0227#EntryCriteria_CDR0000301563 |
| 6 | http://www.cancer.gov/clinicaltrials/RTOG-0227 |
| 7 | http://cancer.gov/clinicaltrials |
| 8 | http://clinicaltrials.gov/ct/show/NCT00068250 |
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