High-Dose (HD) Methotrexate (MTX) Induction Chemotherapy Followed by Alternative HD MTX-based and HD Cytarabine-based Combination Consolidation Chemotherapy for Newly Diagnosed Primary CNS Lymphoma; CISL 10-01 Study

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01083342

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the complete response (CR) rate after HD-MTX induction chemotherapy followed by alternative HD MTX-based and HD Cytarabine-based combination consolidation chemotherapy

Condition or Disease	Intervention/Treatment	Phase
CNS Lymphoma	Drug: MTX, MVD, VIA	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open-labeled, Multicenter Phase II Study of High-Dose (HD) Methotrexate (MTX) Induction Chemotherapy Followed by Alternative HD MTX-based and HD Cytarabine-based Combination Consolidation Chemotherapy for Newly Diagnosed Primary CNS Lymphoma; CISL 10-01 Study

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Outcome Measures

Primary Outcome Measures

To evaluate the complete response (CR) after chemotherapy [24 months]

Secondary Outcome Measures

To evaluate the duration of response [24 months]
To evaluate the progression-free survival, overall survival [24 months]
To evaluate the safety profiles [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

Histologically confirmed Primary Central Nervous System (CNS) lymphoma
Previously untreated. Patients treated with steroid alone are eligible.
Performance status: ECOG 0-3.
Age; 20-70
Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL/min
Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value & Bilirubin < 2 X upper normal value
Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL
At least one cerebral mass lesion on magnetic resonance imaging (MRI) without involvement beyond the central nervous system (CNS)
Life expectancy > 6 months
A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are < 1 years after the onset of menopause.
Informed consent

Exclusion criteria

Other subtypes NHL than Primary Central Nervous System (CNS) lymphoma
Systemic involvement of Primary CNS lymphoma except leptomeningeal involvement
Intraocular lymphoma
HIV (+)
Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Other serious illness or medical conditions

Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
History of significant neurological or psychiatric disorders
Active uncontrolled infection (viral, bacterial or fungal infection)

Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.