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Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma Clinical research trials and Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma. Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma clinical trial. Human subjects often get the best healthcare possible for their Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma  Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
For Condition: primary central nervous system lymphoma
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Drugs used in immunotherapy such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells, and may make cancer cells more sensitive to chemotherapy. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving lower doses of radiation may cause less damage to normal tissue. PURPOSE: Phase II trial to study the effectiveness of combining immunotherapy with combination chemotherapy followed by low-dose radiation therapy and cytarabine in treating patients who have newly diagnosed primary central nervous system lymphoma.
Details: OBJECTIVES: - Determine the efficacy of induction immunochemotherapy comprising rituximab, methotrexate, procarbazine, and vincristine followed by reduced-dose radiotherapy and consolidation cytarabine in patients with newly diagnosed primary central nervous system lymphoma. - Determine the 2-year and overall disease-free survival of patients treated with this regimen. - Determine the progression-free and overall survival of patients treated with this regimen. - Determine the acute treatment-related toxicity and safety of this regimen in these patients. - Determine the initial response rate of patients treated with immunochemotherapy. - Determine the relapse rate after complete response in patients treated with this regimen. - Determine the neuro-cognitive outcome in patients treated with this regimen. OUTLINE: This is a multicenter, pilot study. - Induction immunochemotherapy: Patients receive rituximab IV over 5 hours on day 1 and methotrexate IV over 2 hours and vincristine IV over several minutes on day 2. Patients also receive oral procarbazine on days 2-8 during courses 1, 3, and 5. Treatment repeats every 2 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response after 5 courses may receive an additional 2 courses. - Radiotherapy: Beginning 3-5 weeks after completion of induction immunochemotherapy, patients undergo radiotherapy daily 5 days a week for 3-6 weeks. - Consolidation chemotherapy: Patients receive cytarabine IV over 3 hours on days 1 and 2. Treatment repeats every 28 days for a total of 2 courses. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary non-Hodgkin's lymphoma by brain biopsy - Patients who have an inconclusive biopsy or who are not a candidate for biopsy are eligible provided they have a typical cranial MRI or CT scan* AND meet at least 1 of the following criteria: - Positive cerebrospinal fluid cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers - Biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma NOTE: *Typical MRI or CT scan is defined as the presence of hypo-, iso-, or hyperdense parenchymal contrast-enhancing (usually homogeneously) mass lesion(s) - HIV-1 negative - Normal or negative pretreatment systemic evaluation including the following examinations: - Bone marrow aspirate and biopsy - CT scans of the chest, abdomen, and pelvis PATIENT CHARACTERISTICS: Age - Any age Performance status - Not specified Life expectancy - At least 8 weeks Hematopoietic - WBC at least 4,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2.0 mg/dL - SGOT no greater than 2 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 50 mL/min Other - Not pregnant - Fertile patients must use effective contraception during and for 6 months after study participation - No other active primary malignancy except basal cell skin cancer or carcinoma in situ of the cervix - No pre-existing immunodeficiency (e.g., renal transplantation recipient) - Must maintain a tyramine-free diet (i.e., free of alcohol and certain cheeses) during procarbazine administration PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for CNS lymphoma Endocrine therapy - Not specified Radiotherapy - No prior cranial radiotherapy Surgery - Not specified Other - No citrus fruit, citrus fruit juices, or ascorbic acid supplements during and for 72 hours after methotrexate administration
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LaurenAbrey, Study Chair, Memorial Sloan-Kettering Cancer Center
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15236
United States
Recruiting Alexander Torres-Trejo 412-692-2600
Cancer Center at the University of Virginia *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting David Schiff 434-924-9333
Kentuckiana Cancer Institute *Recruiting*
Louisville, Kentucky, 40202
United States
Recruiting Renato LaRocca 502-561-8200
Vermont Cancer Center at University of Vermont *Recruiting*
Burlington, Vermont, 05401-3498
United States
Recruiting Barbara Grant 802-847-8400
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Lauren Abrey 212-639-5122
Additional Information:
Study ID Numbers: CDR0000298992; MSKCC-01146
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059956
Other Primary Central Nervous System Lymphoma Studies:
1. Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
2. Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
3. Methotrexate, Procarbazine, Lomustine, Dexamethasone, and Cytarabine in Treating Patients With Primary CNS Lymphoma
4. Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma
5. Methotrexate, Cyclophosphamide, and Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Dexamethasone and Cytarabine in Treating Patients With Primary CNS Lymphoma
Related Studies:
Other primary central nervous system lymphoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
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