B Cell Lymphoma, Solid Tumors
Conditions
Keywords
Advanced solid tumors, B cell lymphoma
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.
Interventions
DRUGDecitabine
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.
BIOLOGICALcytokine-induced killer cell
Autologous cytokine-induced killer cells may be used for patients before and after decitabine treatment.
Sponsors
Han weidong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response confirmed by non-investigational CT or MRI, or confirmed by biopsy | within the first 30 days after four-cycle treatment |
Secondary
| Measure | Time frame |
|---|---|
| tumor marker | at least once within 30 days afther completing four-cycle treatment |
Countries
China
Outcome results
None listed