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:
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01083342
First received: March 8, 2010
Last updated: May 22, 2012
Last verified: May 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Samsung Medical Center:

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

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

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Won Seog Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01083342     History of Changes
Other Study ID Numbers: 2009-12-087
Study First Received: March 8, 2010
Last Updated: May 22, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by 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
Cytarabine
Methotrexate
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014