Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lymphoma |
Drug: Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma |
- To determine safety and efficacy of combined immunochemotherapy followed by reduced dose radiation for patients wth newly diagnosed PCNSL. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
- Acute treatment related toxicity. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
- Overall 2 year disease free survival. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
- Response rate to initial combined immunochemotherapy. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Relapse rate following complete response. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Overall and progression free survival. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Neuro-cognitive outcome. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
| Enrollment: | 52 |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine
Immunochemotherapy
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 positive cerebrospinal fluid (CSF) cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers
- A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma
- 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:
- A bone marrow aspirate and biopsy
- CT scans of the chest, abdomen and pelvis
- Patients must have adequate bone marrow function (defined as peripheral leucocyte count > 4000 cells/mm3 and platelet count > 100,000 cells/mm3), liver function (bilirubin < 2.0 mg and SGOT < 2 times upper limit of normal), and adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance > 50 cc/min/1.73M2)
- 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:
- Prior cranial irradiation
- Other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ
- Pre-existing immunodeficiency such as renal transplant recipient
- Prior treatment with chemotherapy for CNS lymphoma
Contacts and Locations| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Principal Investigator: | Antonio Omuro, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00594815 History of Changes |
| Obsolete Identifiers: | NCT00059956 |
| Other Study ID Numbers: | 01-146 |
| Study First Received: | January 7, 2008 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Lymphoma Central Nervous System |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Methotrexate Rituximab Procarbazine Vincristine Leucovorin Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 19, 2013