Status:
UNKNOWN
Lower Dose Decitabine Based Therapy in Patients With Refractory and/or Chemotherapy Resistant Solid Tumors or B Cell Lymphomas
Lead Sponsor:
Han weidong
Conditions:
Solid Tumors
B Cell Lymphoma
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
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 Ce...
Detailed Description
The purpose of this study is to determine whether lower dose decitabine based therapy is safe and can effectively control tumor progression.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01799083
Start Date
December 1 2012
End Date
December 1 2017
Last Update
January 28 2016
Active Locations (1)
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1
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853