FindTrial
Sign In

RANDOMIZED PHASE II ASSAY OF CHEMOTHERAPY WITH METOTREXATE IN HIGH DOSES ONLY OR ASSOCIATED WITH CITARABINE IN HIGH DOSE, FOLLOWED BY RADIOTHERAPY ADEQUATE TO AGE AND RESPONSE FOR IMMUNOCOMPROMISED PATIENTS WITH RECENT DIAGNOSIS OF PRIMARY LYMPHOMA OF THE CENTRAL NERVOUS SYSTEM

RANDOMIZED PHASE II ASSAY OF CHEMOTHERAPY WITH METOTREXATE IN HIGH DOSES ONLY OR ASSOCIATED WITH CITARABINE IN HIGH DOSE, FOLLOWED BY RADIOTHERAPY ADEQUATE TO AGE AND RESPONSE FOR IMMUNOCOMPROMISED PATIENTS WITH RECENT DIAGNOSIS OF PRIMARY LYMPHOMA OF THE CENTRAL NERVOUS SYSTEM.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-082-03
Enrollment
Unknown
Registered
2004-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Methotrexate 3.5 gr / m2 Type of group
Methotrexate 3.5 g / m2 will be administered every day for 3 weeks. Group name:Methotrexate 3.5gr / m2 plus Ara-C 2 gr / m2 Type of group
Methotrexate 3.5 gr m2 (one day) and ARA-C 2 gr / m2 (2-3 days) every 3 weeks.

Sponsors

INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Histological or cytological diagnosis of non-Hodgkins liymphoma. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy. Disease exciusively localized into the central nervous system, cranial nerves or eyes. Untreated patients (patients treated with steroids alone are eligibie). At least one measurable lesion. Age 18-75 years. ECOG performance status < 3

Exclusion criteria

Exclusion criteria: Not contemplated

Design outcomes

Primary

MeasureTime frame
Outcome name:• Complete response (CR): disappearance of the evidence of Lymphoma without the use of corticosteroids in the last two weeks. • Partial response (PR):> 50% decrease in tumor size, with stable or reduced doses of corticosteroids. • Disease progression (PE):> 25% increases the size of the tumor or a new lesion. • Disease Stabilization (SE): No variations. Measure:Association of Cytarabine and Methotrexate is more effective than treatment with Methotrexate as a single agent, in terms of frequency and duration of remission. Timepoints:each week—

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)