Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine - Full Text View

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

This study is currently recruiting participants.

Verified by Assistance Publique - Hôpitaux de Paris, July 2007

First Received: July 18, 2007 Last Updated: July 20, 2007 History of Changes

Sponsor:	Assistance Publique - Hôpitaux de Paris
Collaborators:	ANOCEF – Association de Neuro-Oncologues d’Expression Francaise Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00503594

Purpose

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

Condition	Intervention	Phase
Lymphoma	Drug: Methotrexate and temozolomide Drug: Methotrexate , procarbazine ,vincristine ,cytarabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Vincristine Methotrexate Cytarabine hydrochloride Temozolomide Cytarabine Procarbazine hydrochloride Procarbazine Vincristine sulfate

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Progression-free survival [ Time Frame: at one year ]

Secondary Outcome Measures:

Overall survival:median and overall survival [ Time Frame: at one and two years ]
Response rates [ Time Frame: at end of treatment ]
Toxicity [ Time Frame: during treatment ]
Late toxicity [ Time Frame: 2 to 5 years after treatment ]

Estimated Enrollment:	92
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2012

Arms	Assigned Interventions
2: Active Comparator Comparative evaluation of the efficiency of a new protocol of the primitive lymphome of the central nervous system ( LPSNC) to the old subject, associating Méthotrexate and Témozolomide with regard to a standard protocol associating Méthotrexate, Procarbazine, Vincristine and Cytarabine.	Drug: Methotrexate and temozolomide Drug: Methotrexate , procarbazine ,vincristine ,cytarabine

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

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503594

Contacts

Contact: Antonio OMURO, MD,PhD

+ 33(0) 1 42 16 41 60

antonio.omuro@psl.aphp.fr

Locations

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

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

ANOCEF – Association de Neuro-Oncologues d’Expression Francaise

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Investigators

Principal Investigator:

Antonio OMURO, MD,

Assistance Publique - Hôpitaux de Paris

More Information

Additional Information:

A review on chemotherapy options for primary central nervous system lymphoma This link exits the ClinicalTrials.gov site

Publications:

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

Study ID Numbers:	P060239, AOM06175
Study First Received:	July 18, 2007
Last Updated:	July 20, 2007
ClinicalTrials.gov Identifier:	NCT00503594 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Primary central nervous system lymphoma
Brain lymphoma
Elderly
Chemotherapy
Methotrexate

Temozolomide
Procarbazine
Vincristine
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Abortifacient Agents
Methotrexate
Alkylating Agents
Dermatologic Agents
Lymphoma
Nucleic Acid Synthesis Inhibitors

Cytarabine
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Mitosis Modulators
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Temozolomide
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases

ClinicalTrials.gov processed this record on November 27, 2009