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

• ClinicalTrials.gov Identifier: NCT01799083
• Recruitment Status: Unknown
• First Posted: February 26, 2013
• Last Update Posted: January 28, 2016
• Sponsor: Han weidong
• Information provided by (Responsible Party): Han weidong, Chinese PLA General Hospital

Tracking Information

• First Submitted Date: February 22, 2013
• First Posted Date: February 26, 2013
• Last Update Posted Date: January 28, 2016
• Study Start Date: December 2012
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 26, 2013): Response confirmed by non-investigational CT or MRI, or confirmed by biopsy [ Time Frame: within the first 30 days after four-cycle treatment ]
• Original Primary Outcome Measures (submitted: February 22, 2013): Response confirmed by non-investigational CT or MRI [ Time Frame: within the first 30 days after the fourth cycle ]
• Current Secondary Outcome Measures (submitted: February 26, 2013): tumor marker [ Time Frame: at least once within 30 days afther completing four-cycle treatment ]
• Original Secondary Outcome Measures (submitted: February 22, 2013): tumor marker [ Time Frame: within 30 days afther the fourth cycle ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lower Dose Decitabine Based Therapy in Patients With Refractory and/or Chemotherapy Resistant Solid Tumors or B Cell Lymphomas
• Official Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Solid Tumors
• B Cell Lymphoma

Intervention

• Drug: Decitabine
  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.
  Other Name: Dacogen
• Biological: cytokine-induced killer cell
  Autologous cytokine-induced killer cells may be used for patients before and after decitabine treatment.
  Other Name: CIK transfusion

Study Arms

Experimental: Decitabine

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.

Interventions:

• Drug: Decitabine
• Biological: cytokine-induced killer cell

Publications *

• Lu XC, Yang B, Yu RL, Chi XH, Tuo S, Tuo CW, Zhu HL, Wang Y, Jiang CG, Fu XB, Yang Y, Liu Y, Yao SQ, Dai HR, Cai L, Li BJ, Han WD. Clinical study of autologous cytokine-induced killer cells for the treatment of elderly patients with diffuse large B-cell lymphoma. Cell Biochem Biophys. 2012 Jan;62(1):257-65. doi: 10.1007/s12013-011-9273-6.
• Yang B, Lu XC, Yu RL, Chi XH, Liu Y, Wang Y, Dai HR, Zhu HL, Cai LL, Han WD. Repeated transfusions of autologous cytokine-induced killer cells for treatment of haematological malignancies in elderly patients: a pilot clinical trial. Hematol Oncol. 2012 Sep;30(3):115-22. doi: 10.1002/hon.1012. Epub 2011 Aug 23.
• Fan H, Lu X, Wang X, Liu Y, Guo B, Zhang Y, Zhang W, Nie J, Feng K, Chen M, Zhang Y, Wang Y, Shi F, Fu X, Zhu H, Han W. Low-dose decitabine-based chemoimmunotherapy for patients with refractory advanced solid tumors: a phase I/II report. J Immunol Res. 2014;2014:371087. doi: 10.1155/2014/371087. Epub 2014 May 21.
• Zhang Y, Wang J, Wang Y, Lu XC, Fan H, Liu Y, Zhang Y, Feng KC, Zhang WY, Chen MX, Fu X, Han WD. Autologous CIK cell immunotherapy in patients with renal cell carcinoma after radical nephrectomy. Clin Dev Immunol. 2013;2013:195691. doi: 10.1155/2013/195691. Epub 2013 Dec 9.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 22, 2013): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2017
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01799083
• Other Study ID Numbers: CHN-PLAGH-BT-002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Han weidong, Chinese PLA General Hospital
• Study Sponsor: Han weidong
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Chinese PLA General Hospital
• Verification Date: January 2016