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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
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
First received: July 18, 2007
Last updated: July 27, 2012
Last verified: July 2007
  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 2

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:


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:
Publications:
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: July 27, 2012
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 April 17, 2014