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Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine (CNSLymphoma)

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ClinicalTrials.gov Identifier: NCT00503594
Recruitment Status : Unknown
Verified July 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : July 19, 2007
Last Update Posted : July 30, 2012
French Innovative Leukemia Organisation
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The purpose of this study is to evaluate two types of chemotherapy for primary central nervous system lymphoma in the elderly (age older than 60) :

  • Methotrexate, procarbazine, vincristine and cytarabine
  • Methotrexate and temozolomide

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Methotrexate and temozolomide Drug: Methotrexate , procarbazine ,vincristine ,cytarabine Phase 2

Detailed Description:

The aim of the study is to evaluate efficacy and toxicity associated with both protocols in this population, without radiotherapy.

Patients will be randomized to receive one of the two regimens in one of the participating centers. Neuropsychological evaluation will be performed in all patients. Patients will be followed with serial MRIs.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly
Study Start Date : July 2007
Primary Completion Date : July 2010
Estimated Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: 1
Comparative evaluation of the efficiency of a new protocol of the primitive LYMPHOME of the central nervous system ( LPSNC) to the old subject, associating Methotrexate and Temozolomide with regard to a standard protocol associating Methotrexate, Procarbazine, Vincristine and Cytarabine.
Drug: Methotrexate and temozolomide
Methotrexate and temozolomide
Active Comparator: bras conventional
bras conventional
Drug: Methotrexate , procarbazine ,vincristine ,cytarabine
Methotrexate , procarbazine ,vincristine ,cytarabine

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: at one year ]

Secondary Outcome Measures :
  1. Overall survival:median and overall survival [ Time Frame: at one and two years ]
  2. Response rates [ Time Frame: at end of treatment ]
  3. Toxicity [ Time Frame: during treatment ]
  4. Late toxicity [ Time Frame: 2 to 5 years after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • primary central nervous system lymphoma histologically confirmed by brain biopsy, CSF cytology or vitrectomy
  • KPS 40 or higher
  • Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan
  • Leucocytes>3.500/mm3, platelets>130.000/mm3, Bilirubin < 2 mg, transaminases < 2.5 N), creatinine < 150 μM/l, creatinine clearance > 40 ml/min
  • Age ≥ 60 years
  • Negative HIV test
  • Signature of informed consent

Exclusion Criteria:

  • previous cranial radiotherapy
  • prior chemotherapy for primary central nervous system lymphoma
  • presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ )
  • systemic lymphoma (outside the CNS)
  • Isolated ocular lymphoma
  • Immunosuppressed patients (HIV , use of immunosuppressors)
  • Other uncontrolled or progressive disease compromising shot-term survival
  • Severe renal or hepatic disease
  • Patients not legally covered by the French Social Security
  • Inability to swallow the medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503594

Contact: Antonio OMURO, MD,PhD + 33(0) 1 42 16 41 60 antonio.omuro@psl.aphp.fr

Groupe hospitalier la Pitié Salpétrière Recruiting
Paris, France, 75013
Contact: Antonio OMURO, MD,PhD    + 33(0) 1 42 16 41 60    antonio.omuro@psl.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
French Innovative Leukemia Organisation
Principal Investigator: Antonio OMURO, MD, Assistance Publique - Hôpitaux de Paris

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00503594     History of Changes
Other Study ID Numbers: P060239
First Posted: July 19, 2007    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Primary central nervous system lymphoma
Brain lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents