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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Methotrexate and temozolomide
Methotrexate , procarbazine ,vincristine ,cytarabine
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Primary central nervous system lymphoma, Brain lymphoma, Elderly, Chemotherapy, Methotrexate, Temozolomide, Procarbazine, Vincristine, Cytarabine

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Groupe hospitalier la Pitié SalpétrièreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

bras conventional

Arm Description

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.

bras conventional

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival:median and overall survival
Response rates
Toxicity
Late toxicity

Full Information

First Posted
July 18, 2007
Last Updated
July 27, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
French Innovative Leukemia Organisation
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1. Study Identification

Unique Protocol Identification Number
NCT00503594
Brief Title
Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine
Acronym
CNSLymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
French Innovative Leukemia Organisation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Primary central nervous system lymphoma, Brain lymphoma, Elderly, Chemotherapy, Methotrexate, Temozolomide, Procarbazine, Vincristine, Cytarabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
bras conventional
Arm Type
Active Comparator
Arm Description
bras conventional
Intervention Type
Drug
Intervention Name(s)
Methotrexate and temozolomide
Intervention Description
Methotrexate and temozolomide
Intervention Type
Drug
Intervention Name(s)
Methotrexate , procarbazine ,vincristine ,cytarabine
Intervention Description
Methotrexate , procarbazine ,vincristine ,cytarabine
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
at one year
Secondary Outcome Measure Information:
Title
Overall survival:median and overall survival
Time Frame
at one and two years
Title
Response rates
Time Frame
at end of treatment
Title
Toxicity
Time Frame
during treatment
Title
Late toxicity
Time Frame
2 to 5 years after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio OMURO, MD,PhD
Phone
+ 33(0) 1 42 16 41 60
Email
antonio.omuro@psl.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio OMURO, MD,
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe hospitalier la Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio OMURO, MD,PhD
Phone
+ 33(0) 1 42 16 41 60
Email
antonio.omuro@psl.aphp.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
17134114
Citation
Omuro AM, Abrey LE. Chemotherapy for primary central nervous system lymphoma. Neurosurg Focus. 2006 Nov 15;21(5):E12. doi: 10.3171/foc.2006.21.5.13.
Results Reference
result
PubMed Identifier
26688235
Citation
Omuro A, Chinot O, Taillandier L, Ghesquieres H, Soussain C, Delwail V, Lamy T, Gressin R, Choquet S, Soubeyran P, Huchet A, Benouaich-Amiel A, Lebouvier-Sadot S, Gyan E, Touitou V, Barrie M, del Rio MS, Gonzalez-Aguilar A, Houillier C, Delgadillo D, Lacomblez L, Tanguy ML, Hoang-Xuan K. Methotrexate and temozolomide versus methotrexate, procarbazine, vincristine, and cytarabine for primary CNS lymphoma in an elderly population: an intergroup ANOCEF-GOELAMS randomised phase 2 trial. Lancet Haematol. 2015 Jun;2(6):e251-9. doi: 10.1016/S2352-3026(15)00074-5. Epub 2015 Jun 3.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov
Description
A review on chemotherapy options for primary central nervous system lymphoma

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Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine

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