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| Name | Class |
|---|---|
| Northwestern Memorial Hospital | OTHER |
| Columbia University | OTHER |
| Kentuckiana Cancer Institute | OTHER |
| University of Virginia |
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The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare tumor. It is usually treated with chemotherapy and radiation. This combination prolongs survival, but about half of patients relapse. The investigators hope that the addition of rituximab will improve the control of the tumor.
The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare tumor. It is usually treated with chemotherapy and radiation. This combination prolongs survival, but about half of patients relapse. We hope that the addition of rituximab will improve the control of your tumor.
The second goal of this study is to assess a lower dose of brain radiation. Brain radiation may cause memory loss or dementia. For patients over the age of 60, the risk of significant memory loss is 80-90%. The risk for younger patients is smaller but less clear. In this, study patients whose tumors are in remission after chemotherapy will be treated with a lower dose of brain radiation. We hope that this lower dose will be less toxic. However, it is also possible that using a lower dose of radiation will be less effective in controlling your tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine | Drug | Immunochemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Participants Who Experienced Acute Treatment Related Adverse Events | The toxicity of this combined regimen will be measured using the NCI CTC version 2.0. | 2 years |
| Progression Free Survival | Overall Progression Free Survival at 2 years | 2 Years |
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Inclusion Criteria:
All patients must have a histologic diagnosis of non-Hodgkin's lymphoma by brain biopsy. Patients who have an inconclusive biopsy or who are not candidates for biopsy may be eligible provided they have a typical cranial magnetic resonance imaging (MRI) or computed tomography (CT) scan and meet at least one of the following two criteria:
A typical MRI/CT scan for primary intracranial lymphoma is defined as the presence of hypo, iso, or hyperdense parenchymal contrast-enhancing (usually homogeneously) mass lesion(s)
Patients must be HIV-1 negative
Patients must have a normal or negative pre-treatment systemic evaluation including:
Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment
Exclusion Criteria:
The following would exclude a patient from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Omuro, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24101038 | Derived | Morris PG, Correa DD, Yahalom J, Raizer JJ, Schiff D, Grant B, Grimm S, Lai RK, Reiner AS, Panageas K, Karimi S, Curry R, Shah G, Abrey LE, DeAngelis LM, Omuro A. Rituximab, methotrexate, procarbazine, and vincristine followed by consolidation reduced-dose whole-brain radiotherapy and cytarabine in newly diagnosed primary CNS lymphoma: final results and long-term outcome. J Clin Oncol. 2013 Nov 1;31(31):3971-9. doi: 10.1200/JCO.2013.50.4910. Epub 2013 Oct 7. |
| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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Protocol Open to Accrual 08/08/2002 Protocol Closed to Accrual 03/10/2009 Primary Completion Date 02-23-2016 Recruitment Location is the medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma | Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| OTHER |
| University of Vermont | OTHER |
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| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma | Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Participants Who Experienced Acute Treatment Related Adverse Events | The toxicity of this combined regimen will be measured using the NCI CTC version 2.0. | Posted | Count of Participants | Participants | 2 years |
|
|
| |||||||||||||||||||||||||||
| Primary | Progression Free Survival | Overall Progression Free Survival at 2 years | Posted | Number | 95% Confidence Interval | percentage of participants | 2 Years |
|
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|
Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma | This is a single-armed pilot study designed to evaluate the safety and efficacy of combined immunochemotherapy followed by reduced dose radiation for participants with newly diagnosed PCNSL. | 13 | 52 | 22 | 52 | 43 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Elevated Creatinine | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hallucinations | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Mood alteration-anxiety | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Mood alteration - depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Radiation mucositis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neurology, other | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Pain, other | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Personality/behavior | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Pulmonary, other | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Renal/GU, other | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vision-double vision | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Wound, infectious | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemoglobin/Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Leukocytes | Immune system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| SGPT (ALT) | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Lymphopenia | Immune system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| SGOT (AST) | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| PT | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| PTT | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Creatinine | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bilirubin | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Antonio Omuro | Memorial Sloan Kettering Cancer Center | 212-639-7523 | omuroa@mskcc.org |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D002955 | Leucovorin |
| D008727 | Methotrexate |
| D011344 | Procarbazine |
| D000069283 | Rituximab |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D000630 | Aminopterin |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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| Categories |
|---|
|