Clinical trial NCT00503594: Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: Primary central nervous system lymphoma
Brain lymphoma
Elderly
Chemotherapy
Methotrexate
Temozolomide
Procarbazine
Vincristine
Cytarabine
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: French Innovative Leukemia Organisation
First posted: 2007-07-19
Enrollment: 92
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free survival
timeFrame: at one year
Secondary outcomes:
measure: Overall survival:median and overall survival
timeFrame: at one and two years
measure: Response rates
timeFrame: at end of treatment
measure: Toxicity
timeFrame: during treatment
measure: Late toxicity
timeFrame: 2 to 5 years after treatment
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe hospitalier la Pitié Salpétrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Antonio OMURO, MD,
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.