Phase II Trial of Combined Modality Treatment in Primary Central Nervous System Lymphoma

Lymphoma, B Cell Clinical Trial

Official title:

Randomized Phase II Trial on Primary Chemotherapy With High-dose Methotrexate, Alone or Associated With High-dose Cytarabine, Followed by Response- and Age-tailored Radiotherapy for Immunocompetent Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210314
• Other study ID #: IELSG20
• 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

• Lymphoma
• Lymphoma, B Cell
• Lymphoma, B-Cell

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

External Links

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