- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01799083
Lower Dose Decitabine Based Therapy in Patients With Refractory and/or Chemotherapy Resistant Solid Tumors or B Cell Lymphomas (CIK)
January 26, 2016 updated by: Han weidong
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100853
- Recruiting
- Biotherapeutic Department of Chinese PLA General Hospital
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Contact:
- Wei D Han, Doctor
- Phone Number: +86-10-66937463
- Email: hanwdrsw@sina.com
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Contact:
- Xue C Lu, Doctor
- Phone Number: +86-10-66876237
- Email: luxuechun@126.com
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Sub-Investigator:
- Yang Liu, Master
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Sub-Investigator:
- Bo Yang, Doctor
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Sub-Investigator:
- Yao Wang, Master
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Principal Investigator:
- Wei D Han, Doctor
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Sub-Investigator:
- Xue C Lu, Doctor
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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.
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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 Names:
Autologous cytokine-induced killer cells may be used for patients before and after decitabine treatment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response confirmed by non-investigational CT or MRI, or confirmed by biopsy
Time Frame: within the first 30 days after four-cycle treatment
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within the first 30 days after four-cycle treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tumor marker
Time Frame: at least once within 30 days afther completing four-cycle treatment
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at least once within 30 days afther completing four-cycle treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lu XC, Yang B, Yu RL, Chi XH, Tuo S, Tuo CW, Zhu HL, Wang Y, Jiang CG, Fu XB, Yang Y, Liu Y, Yao SQ, Dai HR, Cai L, Li BJ, Han WD. Clinical study of autologous cytokine-induced killer cells for the treatment of elderly patients with diffuse large B-cell lymphoma. Cell Biochem Biophys. 2012 Jan;62(1):257-65. doi: 10.1007/s12013-011-9273-6.
- Yang B, Lu XC, Yu RL, Chi XH, Liu Y, Wang Y, Dai HR, Zhu HL, Cai LL, Han WD. Repeated transfusions of autologous cytokine-induced killer cells for treatment of haematological malignancies in elderly patients: a pilot clinical trial. Hematol Oncol. 2012 Sep;30(3):115-22. doi: 10.1002/hon.1012. Epub 2011 Aug 23.
- Fan H, Lu X, Wang X, Liu Y, Guo B, Zhang Y, Zhang W, Nie J, Feng K, Chen M, Zhang Y, Wang Y, Shi F, Fu X, Zhu H, Han W. Low-dose decitabine-based chemoimmunotherapy for patients with refractory advanced solid tumors: a phase I/II report. J Immunol Res. 2014;2014:371087. doi: 10.1155/2014/371087. Epub 2014 May 21.
- Zhang Y, Wang J, Wang Y, Lu XC, Fan H, Liu Y, Zhang Y, Feng KC, Zhang WY, Chen MX, Fu X, Han WD. Autologous CIK cell immunotherapy in patients with renal cell carcinoma after radical nephrectomy. Clin Dev Immunol. 2013;2013:195691. doi: 10.1155/2013/195691. Epub 2013 Dec 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (ANTICIPATED)
December 1, 2016
Study Completion (ANTICIPATED)
December 1, 2017
Study Registration Dates
First Submitted
February 22, 2013
First Submitted That Met QC Criteria
February 22, 2013
First Posted (ESTIMATE)
February 26, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
January 28, 2016
Last Update Submitted That Met QC Criteria
January 26, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Decitabine
Other Study ID Numbers
- CHN-PLAGH-BT-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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