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

Sponsor:	Assistance Publique - Hôpitaux de Paris
Collaborator:	Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Estimated Enrollment:	92
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2012
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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 Methotrexate and temozolomide Other Name: Methotrexate and temozolomide
Active Comparator: bras conventional bras conventional	Drug: Methotrexate , procarbazine ,vincristine ,cytarabine Methotrexate , procarbazine ,vincristine ,cytarabine Other Name: 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

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.

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00503594 History of Changes
Other Study ID Numbers:	P060239
Study First Received:	July 18, 2007
Last Updated:	November 9, 2011
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:

Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Methotrexate
Temozolomide
Procarbazine
Vincristine
Dacarbazine
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on February 12, 2012