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

CNS Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083342
• Other study ID #: 2009-12-087
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2010
• Last updated: May 22, 2012
• Start date: January 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• CNS Lymphoma
• Lymphoma

Intervention

Drug:
• MTX, MVD, VIA
MTX: Methotrexate,Leucovorin MVD: Methotrexate,Vincristine,Dexamethasone VIA: VP-16 (Etoposide),Ifosfamide,Mesna, Cytarabine (ara-C)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the complete response (CR) after chemotherapy		24 months	Yes
Secondary	To evaluate the duration of response		24 months	Yes
Secondary	To evaluate the progression-free survival, overall survival		24 months	Yes
Secondary	To evaluate the safety profiles		24 months	Yes