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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00210314
Other study ID # IELSG20
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated March 27, 2015
Start date July 2003
Est. completion date December 2007

Study information

Verified date March 2015
Source International Extranodal Lymphoma Study Group (IELSG)
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

Aim of the study is to establish in a prospective, randomized clinical trial the activity of primary chemotherapy containing high dose-methotrexate, alone or combined with high dose cytarabine, in patients with primary central nervous system lymphoma


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date December 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Histological or cytological diagnosis of non-Hodgkin's lymphoma.

2. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.

3. Disease exclusively localized into the central nervous system, cranial nerves or eyes.

4. Untreated patients (patients treated with steroids alone are eligible).

5. At least one measurable lesion.

6. Age 18 - 75 years.

7. ECOG performance status < 3

8. HBsAg-negative and Ab anti-HCV-negative serologic status.

9. No known HIV disease or immunodeficiency.

10. Adequate bone marrow (PLT > 100000 mm3, Hb = 9 g/dl, ANC = 2.000 mm3), renal (creatinine clearance = 60 mL/min), cardiac (VEF = 50%), and hepatic function (total serum bilirubin < 3 mg/dL, AST/ALT and gGT < 2 per upper normal limit value).

11. No previous or concurrent malignancies with the exception of surgically cured cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer and of other cancers without evidence of disease since at least 5 years (patients with a previous lymphoma diagnosis will be excluded).

12. Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

13. Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.

14. No concurrent treatment with other experimental drugs.

15. Informed consent signed by the patient before registration

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
high dose methotrexate

high dose cytarabine

Radiation:
radiotherapy


Locations

Country Name City State
Switzerland Oncology Institute of Southern Switzerland (IOSI) Bellinzona

Sponsors (1)

Lead Sponsor Collaborator
International Extranodal Lymphoma Study Group (IELSG)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary The main endpoint is the complete remission (CR) rate after chemotherapy
Secondary Overall response rate
Secondary Response duration (time to relapse or progression) for responder patients
Secondary Overall survival
Secondary Event-free survival
Secondary Meningeal relapse rate
Secondary Early and late neurotoxicity
See also
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Withdrawn NCT00210340 - A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis Phase 1