Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine

Condition(s) targeted: Lymphoma

Intervention: Methotrexate and temozolomide (Drug); Methotrexate , procarbazine ,vincristine ,cytarabine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Antonio OMURO, MD,, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

Overall contact:
Antonio OMURO, MD,PhD, Phone: + 33(0) 1 42 16 41 60, Email: antonio.omuro@psl.aphp.fr

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

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Progression-free survival

Secondary outcome:

Overall survival:median and overall survival

Response rates

Toxicity

Late toxicity

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.

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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

Antonio OMURO, MD,PhD, Phone: + 33(0) 1 42 16 41 60, Email: antonio.omuro@psl.aphp.fr

Groupe hospitalier la Pitié Salpétrière, PARIS 75013, France; Recruiting
Antonio OMURO, MD,PhD, Phone: + 33(0) 1 42 16 41 60, Email: antonio.omuro@psl.aphp.fr

A review on chemotherapy options for primary central nervous system lymphoma

Starting date: July 2007
Ending date: July 2012
Last updated: July 20, 2007