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

NCT01083342 | Completed Phase 2

• 1 other identifier: 2009-12-087
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• To evaluate the complete response (CR) after chemotherapy

  24 months

Secondary Outcomes (3)

• 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

Interventions

MTX, MVD, VIA DRUG

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

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Officials

• WonSeog Kim,, M.D., PhD.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 24, 2012

Record last verified: 2012-05

Locations

KR (1)