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Trial record 16 of 47 for:    "Central Nervous System Lymphoma" | "Vitamin B Complex"

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

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ClinicalTrials.gov Identifier: NCT01083342
Recruitment Status : Completed
First Posted : March 9, 2010
Last Update Posted : May 24, 2012
Sponsor:
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE March 8, 2010
First Posted Date  ICMJE March 9, 2010
Last Update Posted Date May 24, 2012
Study Start Date  ICMJE January 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2010)
To evaluate the complete response (CR) after chemotherapy [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01083342 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE CNS Lymphoma
Intervention  ICMJE Drug: MTX, MVD, VIA
MTX: Methotrexate,Leucovorin MVD: Methotrexate,Vincristine,Dexamethasone VIA: VP-16 (Etoposide),Ifosfamide,Mesna, Cytarabine (ara-C)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2012)
36
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2010)
51
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01083342
Other Study ID Numbers  ICMJE 2009-12-087
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Won Seog Kim, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: WonSeog Kim, , M.D., PhD. Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP