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

July 27, 2012 updated by: Assistance Publique - Hôpitaux de Paris

Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75013
        • Recruiting
        • Groupe Hospitalier la Pitié Salpêtrière
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Drug: Methotrexate , procarbazine ,vincristine ,cytarabine
Methotrexate , procarbazine ,vincristine ,cytarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: at one year
at one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival:median and overall survival
Time Frame: at one and two years
at one and two years
Response rates
Time Frame: at end of treatment
at end of treatment
Toxicity
Time Frame: during treatment
during treatment
Late toxicity
Time Frame: 2 to 5 years after treatment
2 to 5 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

French Innovative Leukemia Organisation

Investigators

  • Principal Investigator: Antonio OMURO, MD,, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

July 1, 2010

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

July 18, 2007

First Submitted That Met QC Criteria

July 18, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Estimate)

July 30, 2012

Last Update Submitted That Met QC Criteria

July 27, 2012

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P060239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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