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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

Phase 1/Phase 2
18 Years
85 Years
Open (Enrolling)
Solid Tumors, B Cell Lymphoma

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Trial Information

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

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

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response confirmed by non-investigational CT or MRI, or confirmed by biopsy

Outcome Time Frame:

within the first 30 days after four-cycle treatment

Safety Issue:



Chinese PLA General Hospital: China

Study ID:




Start Date:

December 2012

Completion Date:

December 2014

Related Keywords:

  • Solid Tumors
  • B Cell Lymphoma
  • Advanced solid tumors
  • B cell lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Neoplasms