Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Northwestern Memorial Hospital
Columbia University
Kentuckiana Cancer Institute
University of Virginia
University of Vermont
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00594815
First received: January 7, 2008
Last updated: January 27, 2014
Last verified: January 2014

January 7, 2008
January 27, 2014
August 2002
August 2014   (final data collection date for primary outcome measure)
  • 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 ]
To determine safety & efficacy of combined immunochemotherapy followed by reduced dose radiation for patients w/newly diagnosed PCNSL. Acute treatment related toxicity/Overall 2 year disease free survival. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00594815 on ClinicalTrials.gov Archive Site
  • 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 ]
Response rate to initial combined immunochemotherapy/Relapse rate following complete response/Overall & progression free survival/Neuro-cognitive outcome. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Drug: Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine
Immunochemotherapy
Experimental: 1
Intervention: Drug: Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
52
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00594815
01-146
No
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Northwestern Memorial Hospital
  • Columbia University
  • Kentuckiana Cancer Institute
  • University of Virginia
  • University of Vermont
Principal Investigator: Antonio Omuro, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP