Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine

Lymphoma Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00503594
• Other study ID #: P060239
• Status: Recruiting
• Phase: Phase 2
• First received: July 18, 2007
• Last updated: July 27, 2012
• Start date: July 2007
• Est. completion date: July 2012

Study information

• Verified date: July 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Antonio OMURO, MD,PhD
• Phone: + 33(0) 1 42 16 41 60
• Email: antonio.omuro[@]psl.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: July 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

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

Locations

Country	Name	City	State
France	Groupe hospitalier la Pitié Salpétrière	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Country where clinical trial is conducted

France, 

References & Publications (1)

Omuro AM, Abrey LE. Chemotherapy for primary central nervous system lymphoma. Neurosurg Focus. 2006 Nov 15;21(5):E12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		at one year	Yes
Secondary	Overall survival:median and overall survival		at one and two years	Yes
Secondary	Response rates		at end of treatment	Yes
Secondary	Toxicity		during treatment	Yes
Secondary	Late toxicity		2 to 5 years after treatment	Yes

External Links

•   A review on chemotherapy options for primary central nervous system lymphoma