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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Solid Tumors B Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Decitabine

Intervention Type DRUG

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.

cytokine-induced killer cell

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type DRUG

cytokine-induced killer cell

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Dacogen CIK transfusion

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No