|
Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma Clinical research trials and Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma. Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma  Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
For Condition: primary central nervous system lymphoma
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: 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: Phase I/II trial to study the effectiveness of combining methotrexate, rituximab, and temozolomide with radiation therapy in treating patients who have primary central nervous system lymphoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of temozolomide in combination with methotrexate and rituximab before fractionated whole brain radiotherapy in patients with primary central nervous system lymphoma. - Compare the 2-year survival rate of patients receiving this chemotherapy regimen before radiotherapy and temozolomide after radiotherapy to that of patients treated on protocol RTOG-9310. - Compare the tumor response rates of patients treated with this chemotherapy regimen before radiotherapy to that of patients treated on RTOG-9310. - Determine the progression-free survival of patients treated with this regimen. - Determine the acute and long-term neurologic toxicity of this regimen in these patients. - Determine the quality of life of patients treated with this regimen. OUTLINE: This is a phase I dose-escalation study of temozolomide in combination with methotrexate and rituximab before radiotherapy, followed by a phase II study. Phase I - Patients receive rituximab IV 3 days prior to the first course of methotrexate. Patients then receive methotrexate IV over 4 hours on weeks 1, 3, 5, 7, and 9 (for a total of 5 doses). Patients also receive oral temozolomide daily for 5 days on weeks 4 and 8. Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 0 of 3 or 1 of 6 patients experience dose-limiting toxicity. - Radiotherapy: Patients undergo whole brain radiotherapy daily for 5 days on weeks 11, 12, and 13. - Post-radiotherapy chemotherapy: Patients receive oral temozolomide once daily on days 1-5 beginning at week 14. Treatment repeats every 28 days for 10 courses in the absence of unacceptable toxicity. Phase II - Patients receive treatment as in phase I at the MTD of temozolomide. Treatment continues in the absence of unacceptable toxicity. Quality of life is assessed at baseline, at weeks 10 and 13, every 2 months during post-radiotherapy temozolomide therapy, at the end of therapy, and then every 3 months for 2 years, every 6 months for 3 years, and annually for 5 years. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 52-64 patients (up to 18 patients for phase I and 46 patients for phase II) will be accrued for this study within 19 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Cytologically confirmed primary CNS lymphoma - Based on positive biopsy, cerebrospinal fluid, or vitreous cytology (in association with measurable intraparenchymal tumor) - B-cell type - CD20+ disease - Cytology must demonstrate lymphoma OR an immunohistochemical diagnosis of malignant lymphocytes with a monoclonal lymphocytic population - No evidence of systemic lymphoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-2 Life expectancy - At least 8 weeks Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST no greater than 2 times ULN - Alkaline phosphatase no greater than 2 times ULN Renal - Creatinine clearance at least 50 mL/min - No renal insufficiency Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No history of idiopathic sensitivity to any of the drugs in this study - No active infection - No known anaphylaxis or IgE-mediated hypersensitivity to murine proteins or to any component of rituximab PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the brain, head, or neck Surgery - No prior organ transplantation
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonGlass, Study Chair, Fox Chase Cancer Center
Baptist Hospital of Miami *Recruiting*
Miami, Florida, 33256-2110
United States
Recruiting Andre Abitbol 305-596-6566
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Brachman 602-274-4484
Wendt Regional Cancer Center of Finley Hospital *Recruiting*
Dubuque, Iowa, 52001
United States
Recruiting Thomas Lally 319-589-2468
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
West Michigan Cancer Center *Recruiting*
Kalamazoo, Michigan, 49007
United States
Recruiting Contact Person 616-373-7488
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033-0804
United States
Recruiting Oscar Streeter 323-865-3084
Additional Information:
Study ID Numbers: CDR0000301563; RTOG-0227
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068250
Other Primary Central Nervous System Lymphoma Studies:
1. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma
2. Rituximab, Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Sodium Thiosulfate and Cytarabine in Treating Patients With Refractory or Recurrent Primary CNS Lymphoma
3. Methotrexate, Cyclophosphamide, and Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Dexamethasone and Cytarabine in Treating Patients With Primary CNS Lymphoma
4. Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
5. Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
Related Studies:
Other primary central nervous system lymphoma Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
|
|
|
|
|
|
|
|
