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
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