We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01083342
First Posted: March 9, 2010
Last Update Posted: May 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center
  Purpose
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 Intervention Phase
CNS Lymphoma Drug: MTX, MVD, VIA Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Won Seog Kim, Samsung Medical Center:

Primary Outcome Measures:
  • To evaluate the complete response (CR) after chemotherapy [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • To evaluate the duration of response [ Time Frame: 24 months ]
  • To evaluate the progression-free survival, overall survival [ Time Frame: 24 months ]
  • To evaluate the safety profiles [ Time Frame: 24 months ]

Enrollment: 36
Study Start Date: January 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MTX, MVD, VIA
    MTX: Methotrexate,Leucovorin MVD: Methotrexate,Vincristine,Dexamethasone VIA: VP-16 (Etoposide),Ifosfamide,Mesna, Cytarabine (ara-C)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083342


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: WonSeog Kim, , M.D., PhD. Samsung Medical Center
  More Information

Responsible Party: Won Seog Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01083342     History of Changes
Other Study ID Numbers: 2009-12-087
First Submitted: March 8, 2010
First Posted: March 9, 2010
Last Update Posted: May 24, 2012
Last Verified: May 2012

Keywords provided by Won Seog Kim, Samsung Medical Center:
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

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Methotrexate
Cytarabine
Vincristine
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents