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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumors B Cell Lymphoma Drug: Decitabine Biological: cytokine-induced killer cell Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Decitabine

Arms and Interventions
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Arm Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Response confirmed by non-investigational CT or MRI, or confirmed by biopsy [ Time Frame: within the first 30 days after four-cycle treatment ]

Secondary Outcome Measures :
  1. tumor marker [ Time Frame: at least once within 30 days afther completing four-cycle treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01799083


Locations
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China, Beijing
Biotherapeutic Department of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Wei D Han, Doctor    +86-10-66937463    hanwdrsw@sina.com   
Contact: Xue C Lu, Doctor    +86-10-66876237    luxuechun@126.com   
Sub-Investigator: Yang Liu, Master         
Sub-Investigator: Bo Yang, Doctor         
Sub-Investigator: Yao Wang, Master         
Sub-Investigator: Yan Zhang, Doctor         
Principal Investigator: Wei D Han, Doctor         
Sub-Investigator: Xue C Lu, Doctor         
Sponsors and Collaborators
Han weidong
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Han weidong, Researcher, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01799083    
Other Study ID Numbers: CHN-PLAGH-BT-002
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Keywords provided by Han weidong, Chinese PLA General Hospital:
Advanced solid tumors
B cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors