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

NCT00210314 | Completed Phase 2

• 1 other identifier: IELSG20
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lymphoma, B Cell

Outcome Measures

Primary Outcomes (1)

• The main endpoint is the complete remission (CR) rate after chemotherapy

Secondary Outcomes (6)

• Overall response rate

• Response duration (time to relapse or progression) for responder patients

• Overall survival

• Event-free survival

• Meningeal relapse rate

Study Arms (2)

High-dose methotrexate alone

ACTIVE COMPARATOR

Drug: high dose methotrexate; Radiation: radiotherapy

High-dose methotrexate associated with high dose cytarabine

EXPERIMENTAL

Drug: high dose methotrexate; Drug: high dose cytarabine; Radiation: radiotherapy

Interventions

high dose methotrexate DRUG

High-dose methotrexate alone; High-dose methotrexate associated with high dose cytarabine

high dose cytarabine DRUG

High-dose methotrexate associated with high dose cytarabine

radiotherapy RADIATION

High-dose methotrexate alone; High-dose methotrexate associated with high dose cytarabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological diagnosis of non-Hodgkin's lymphoma.
• Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
• Disease exclusively localized into the central nervous system, cranial nerves or eyes.
• Untreated patients (patients treated with steroids alone are eligible).
• At least one measurable lesion.
• Age 18 - 75 years.
• ECOG performance status \< 3
• HBsAg-negative and Ab anti-HCV-negative serologic status.
• No known HIV disease or immunodeficiency.
• 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).
• 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).
• Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
• No concurrent treatment with other experimental drugs.
• Informed consent signed by the patient before registration

Sponsors & Collaborators

• International Extranodal Lymphoma Study Group (IELSG): lead

Study Sites (1)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, 6500, Switzerland

Location

Related Publications (1)

• Ferreri AJ, Reni M, Foppoli M, Martelli M, Pangalis GA, Frezzato M, Cabras MG, Fabbri A, Corazzelli G, Ilariucci F, Rossi G, Soffietti R, Stelitano C, Vallisa D, Zaja F, Zoppegno L, Aondio GM, Avvisati G, Balzarotti M, Brandes AA, Fajardo J, Gomez H, Guarini A, Pinotti G, Rigacci L, Uhlmann C, Picozzi P, Vezzulli P, Ponzoni M, Zucca E, Caligaris-Cappio F, Cavalli F; International Extranodal Lymphoma Study Group (IELSG). High-dose cytarabine plus high-dose methotrexate versus high-dose methotrexate alone in patients with primary CNS lymphoma: a randomised phase 2 trial. Lancet. 2009 Oct 31;374(9700):1512-20. doi: 10.1016/S0140-6736(09)61416-1. Epub 2009 Sep 18.

  PMID: 19767089 DERIVED

Related Links

• Click here for more information about this study

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Methotrexate; Cytarabine; Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Therapeutics

Study Officials

• Andres JM Ferreri, MD

  Radiochemotherapy. San Raffaele Hospital. Milan

  STUDY CHAIR

• Michele Reni, MD

  Radiochemotherapy. San Raffaele Hospital. Milan

  STUDY CHAIR

• Emanuele Zucca, MD

  International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2003
• Primary Completion: September 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 30, 2015

Record last verified: 2015-03

Locations

CH (1)