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

Study Overview
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Brief Summary
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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
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The purpose of this study is to determine whether lower dose decitabine based therapy is safe and can effectively control tumor progression.

Official Title
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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

Conditions
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Solid Tumors, B Cell Lymphoma

Intervention / Treatment
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* Drug: Decitabine
* Biological: cytokine-induced killer cell


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decitabine<br>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<br>* 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.<br>* Other names: Dacogen;Biological: cytokine-induced killer cell<br>* Autologous cytokine-induced killer cells may be used for patients before and after decitabine treatment.<br>* Other names: CIK transfusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response confirmed by non-investigational CT or MRI, or confirmed by biopsy |  | within the first 30 days after four-cycle treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor marker |  | at least once within 30 days afther completing four-cycle treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced solid tumors, B cell lymphoma