NCT00503594

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2007

Enrollment Period

3 years

First QC Date

July 18, 2007

Last Update Submit

July 27, 2012

Conditions

Lymphoma

Keywords

Primary central nervous system lymphomaBrain lymphomaElderlyChemotherapyMethotrexateTemozolomideProcarbazineVincristineCytarabine

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    at one year

Secondary Outcomes (4)

  • Overall survival:median and overall survival

    at one and two years

  • Response rates

    at end of treatment

  • Toxicity

    during treatment

  • Late toxicity

    2 to 5 years after treatment

Study Arms (2)

1

EXPERIMENTAL

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

bras conventional

ACTIVE COMPARATOR

bras conventional

Drug: Methotrexate , procarbazine ,vincristine ,cytarabine

Interventions

Methotrexate and temozolomideDRUG

Methotrexate and temozolomide

1
Methotrexate , procarbazine ,vincristine ,cytarabineDRUG

Methotrexate , procarbazine ,vincristine ,cytarabine

bras conventional

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe hospitalier la Pitié Salpétrière

Paris, 75013, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 17134114RESULT

  • 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.

    PMID: 26688235DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma

Interventions

MethotrexateTemozolomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Antonio OMURO, MD,

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio OMURO, MD,PhD

CONTACT

+ 33(0) 1 42 16 41 60antonio.omuro@psl.aphp.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2007

First Posted

July 19, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2012

Last Updated

July 30, 2012

Record last verified: 2007-07

Locations

FR(1)