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Trial record 4 of 45 for:    Han weidong

Lower Dose Decitabine Based Therapy in Patients With Refractory and/or Chemotherapy Resistant Solid Tumors or B Cell Lymphomas (CIK)

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ClinicalTrials.gov Identifier: NCT01799083
Recruitment Status : Unknown
Verified January 2016 by Han weidong, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : February 26, 2013
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Tracking Information
First Submitted Date  ICMJE February 22, 2013
First Posted Date  ICMJE February 26, 2013
Last Update Posted Date January 28, 2016
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2013)
Response confirmed by non-investigational CT or MRI, or confirmed by biopsy [ Time Frame: within the first 30 days after four-cycle treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2013)
Response confirmed by non-investigational CT or MRI [ Time Frame: within the first 30 days after the fourth cycle ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2013)
tumor marker [ Time Frame: at least once within 30 days afther completing four-cycle treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2013)
tumor marker [ Time Frame: within 30 days afther the fourth cycle ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lower Dose Decitabine Based Therapy in Patients With Refractory and/or Chemotherapy Resistant Solid Tumors or B Cell Lymphomas
Official Title  ICMJE Phase 1/2 Study of Decitabine Alone and/or in Combination With Chemotherapy and/or Cytokine Induced Killer Cell Transfusion in Patients With Relapsed or Refractory Solid Tumors and B Cell Lymphomas
Brief Summary Determine alone or in combination with chemotherapy or autologous cytokine induced killer cells are effective and safe in the treatment of patients with relapsed and/or refractory solid tumors or B Cell lymphomas.
Detailed Description The purpose of this study is to determine whether lower dose decitabine based therapy is safe and can effectively control tumor progression.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumors
  • B Cell Lymphoma
Intervention  ICMJE
  • Drug: Decitabine
    A continuous 5-day lower-dose decitabine transfusion will be performed for patients during each treatment cycle, and autologous cytokine-induced killer cells may be transfused or chemotherapy may be also added.
    Other Name: Dacogen
  • Biological: cytokine-induced killer cell
    Autologous cytokine-induced killer cells may be used for patients before and after decitabine treatment.
    Other Name: CIK transfusion
Study Arms  ICMJE Experimental: Decitabine
A continuous 5-day treatment of lower dose decitabine within 4-6 weeks is regarded as a treatment cycle, transfusion of auto-CIK cells or chemotherapy regimen may be used for patients.
Interventions:
  • Drug: Decitabine
  • Biological: cytokine-induced killer cell
Publications *

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 22, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Solid Tumor

    • Histologically confirmed advanced solid tumor
    • 1 to 3 prior treatment regimens
    • At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional computerized tomography (CT) scanning technique or ≥ 1 cm in the largest dimension by spiral CT scanning (per RECIST criteria); or if, in the Principal Investigator's opinion, evaluable disease can be reliably and consistently followed, the subject may be eligible upon approval by the Medical Monitor
  • B Cell Lymphoma

    • Histologically or cytologically confirmed B Cell Lymphoma.
    • Patients must have had an initial diagnosis of B Cell NHL (including follicular, small lymphocytic, lymphoplasmacytoid, and marginal zone lymphoma), indolent disease that transformed to a more aggressive subtype, as previously described or patients may have mantle cell lymphoma.
    • Patients are required to have received prior chemotherapy (alone or combined with rituximab or other treatment) and are considered refractory to (defined as no response, or progression within 6 months of completing therapy) or intolerant of continued rituximab or other treatment.
    • Patients may have received up to a maximum of four prior unique chemotherapy regimens, including if not contra-indicated autologous stem-cell transplantation (ASCT).
    • For patients to enroll in the expanded dose group for lymphoma, patients must have measurable disease

Exclusion Criteria:

  • Disease Related

    • Chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy, within 3 weeks prior to first dose or 6 weeks for antibody therapy
    • Radiation therapy or immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where 6 weeks is required); localized radiation therapy within 1 week prior to first dose
    • Subjects with prior brain metastases are permitted, but must have completed treatment and have no evidence of active central nervous system (CNS) disease for at least 4 weeks prior to first dose
    • For lymphoma patients; patients with prior stem cell transplant therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks). Patients with prior allogeneic SCT should not have evidence of moderate-to-severe GVHD.
    • Participation in an investigational therapeutic study within 3 weeks prior to first dose
    • Prior treatment with decitabine

Concurrent Conditions

  • Major surgery within 3 weeks prior to first dose
  • Congestive heart failure (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 3 months prior to first dose
  • Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose
  • Known or suspected HIV infection or subjects who are HIV seropositive
  • Active hepatitis A, B, or C infection
  • Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose

Ethical / Other

  • Female subjects who are pregnant or lactating
  • Any clinically significant psychiatric or medical condition that in the opinion of the Investigator could interfere with protocol adherence or a subject's ability to give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01799083
Other Study ID Numbers  ICMJE CHN-PLAGH-BT-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Han weidong, Chinese PLA General Hospital
Study Sponsor  ICMJE Han weidong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese PLA General Hospital
Verification Date January 2016

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