Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Completed · Phase 1/Phase 2

Conditions studied: Brain and Central Nervous System Tumors, Lymphoma

In brief

RATIONALE: 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. PURPOSE: 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.

Key facts

Study ID

NCT00068250

Run by

Radiation Therapy Oncology Group

People needed

60

Starts

2003-07-01

Expected to finish

2016-12-01

Last updated by the study team

2018-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary central nervous system (CNS) lymphoma [B-cell, Cluster of Differentiation 20 (CD20) antigen positive] based on positive biopsy or cerebrospinal fluid (CSF) or vitreous cytology (in association with measurable intraparenchymal tumor). Cytology must demonstrate lymphoma or have an immunohistochemical diagnosis of malignant lymphocytes with a monoclonal lymphocytic population.
• Life expectancy ≥ 8 weeks;
• Zubrod performance status of 0-2;
• Absolute granulocyte count ≥1500/mm3; platelet count ≥ 100,000/mm3; creatinine clearance ≥ 50, calculated with the Cockcroft-Gault Equation: Cr Clearance = (140-age) x wt (kg)/(Cr[mg/dl]x 72); Bilirubin, serum glutamate oxaloacetate transaminase (SGOT), alkaline phosphatase (AST) ≤ 2 x institutional upper limits of normal;
• Patients must sign a study-specific informed consent prior to study entry.
• Age ≥ 18

You may not qualify if…

• Evidence of systemic lymphoma;
• Prior malignancy (excluding in situ carcinoma of the cervix or non-melanomatous skin cancer)unless disease free for at least five years;
• Prior radiotherapy to the brain or head/neck;
• Prior chemotherapy;
• History of idiopathic sensitivity to any of the drugs to be used;
• Active infectious process;
• Seropositive for HIV, AIDS, or post-organ transplant;
• Pregnant women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus.
• Active hepatitis B.

Where it is running

• Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
• Integrated Community Oncology Network at Southside Cancer Center — Jacksonville, Florida, United States
• Baptist Medical Center South — Jacksonville, Florida, United States
• Integrated Community Oncology Network — Jacksonville Beach, Florida, United States
• Integrated Community Oncology Network - Orange Park — Orange Park, Florida, United States
• Florida Cancer Center - Palatka — Palatka, Florida, United States
• Flagler Cancer Center — Saint Augustine, Florida, United States
• Borgess Medical Center — Kalamazoo, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Bronson Methodist Hospital — Kalamazoo, Michigan, United States
• CCOP - Kansas City — Kansas City, Missouri, United States
• Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis — St Louis, Missouri, United States
• CCOP - Nevada Cancer Research Foundation — Las Vegas, Nevada, United States
• John F. Kennedy Medical Center — Edison, New Jersey, United States
• Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
• Providence Milwaukie Hospital — Milwaukie, Oregon, United States
• Providence Cancer Center at Providence Portland Medical Center — Portland, Oregon, United States
• CCOP - Columbia River Oncology Program — Portland, Oregon, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• Kimmel Cancer Center at Thomas Jefferson University - Philadelphia — Philadelphia, Pennsylvania, United States
• Hollings Cancer Center at Medical University of South Carolina — Charleston, South Carolina, United States
• Jon and Karen Huntsman Cancer Center at Intermountain Medical Center — Murray, Utah, United States
• Utah Valley Regional Medical Center - Provo — Provo, Utah, United States
• Southwest Washington Medical Center Cancer Center — Vancouver, Washington, United States
• Community Memorial Hospital Cancer Care Center — Menomonee Falls, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.