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

Solid Tumors Clinical Trial

— CIK  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01799083
• Other study ID #: CHN-PLAGH-BT-002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 22, 2013
• Last updated: January 26, 2016
• Start date: December 2012
• Est. completion date: December 2017

Study information

• Verified date: January 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chinese PLA General Hospital: China
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Solid Tumors

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.

Biological:
• cytokine-induced killer cell
Autologous cytokine-induced killer cells may be used for patients before and after decitabine treatment.

Locations

Country	Name	City	State
China	Biotherapeutic Department of Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Han weidong

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response confirmed by non-investigational CT or MRI, or confirmed by biopsy		within the first 30 days after four-cycle treatment	Yes
Secondary	tumor marker		at least once within 30 days afther completing four-cycle treatment	Yes