Clinical trial NCT01083342: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: CNS Lymphoma
Keywords: primary CNS lymphoma
MTX: Methotrexate,Leucovorin
MVD: Methotrexate,Vincristine,Dexamethasone
VIA: VP-16 (Etoposide),Ifosfamide,Mesna, Cytarabine (ara-C)
Newly diagnosed primary CNS lymphoma patients
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria

1. Histologically confirmed Primary Central Nervous System (CNS) lymphoma
2. Previously untreated. Patients treated with steroid alone are eligible.
3. Performance status: ECOG 0-3.
4. Age; 20-70
5. Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL/min
6. Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value \& Bilirubin \< 2 X upper normal value
7. Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL
8. At least one cerebral mass lesion on magnetic resonance imaging (MRI) without involvement beyond the central nervous system (CNS)
9. Life expectancy \> 6 months
10. 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.
11. Informed consent

Exclusion criteria

1. Other subtypes NHL than Primary Central Nervous System (CNS) lymphoma
2. Systemic involvement of Primary CNS lymphoma except leptomeningeal involvement
3. Intraocular lymphoma
4. HIV (+)
5. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
6. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
7. 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)
8. 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.
9. Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.

Primary outcomes:
measure: To evaluate the complete response (CR) after chemotherapy
timeFrame: 24 months
Secondary outcomes:
measure: To evaluate the duration of response
timeFrame: 24 months
measure: To evaluate the progression-free survival, overall survival
timeFrame: 24 months
measure: To evaluate the safety profiles
timeFrame: 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: WonSeog Kim,, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References: