Status:
COMPLETED
Safety Study Looking at the Use of a Natural Killer Cell Line Against Hematological Malignancies
Lead Sponsor:
University Health Network, Toronto
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find out how many irradiated natural killer (NK) cells can be safely given to patients with cancer that has recurred after an autologous stem cell transplant, and to se...
Detailed Description
Patients with hematological malignancies such as acute leukemia, lymphoma, Hodgkin's disease and myeloma, are generally treated initially with chemotherapy, radiotherapy or a combination of both. High...
Eligibility Criteria
Inclusion
- Hematological malignancy (with prior histological confirmation) that has relapsed after an autologous stem cell transplant and for which there is no known curative or standard therapy. Specific hematological malignancies include acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, Hodgkin's disease and multiple myeloma.
- Assessable disease as measured by clinical, radiological or bone marrow examinations
- ECOG performance status 0, 1 or 2
- Age ≥ 18 years
- Life expectancy greater than 12 weeks
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and University Human Experimentation Committee requirements.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: Absolute granulocytes ≥ 0.5 x 109/L, Platelets ≥ 50 x 109/L, Serum creatinine \< 1.5 x upper limit of normal, Bilirubin \< 1.5 x upper limit of normal, AST/ALT ≤ 3 x upper limit of normal, Calcium \< 1.25 x upper limit of normal. These tests must be conducted within 7 days prior to registration.
- Must be able to come to Princess Margaret Hospital, Toronto, Canada for treatment and follow-up.
Exclusion
- Pregnant or nursing women may not participate.
- Men or women of reproductive potential may not participate unless they agree to practice an effective method of birth control. Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to registration.
- Concurrent treatment, or treatment within 28 days of registration with other experimental drugs or anticancer therapy. Exceptions to this are: Patients who are receiving or who have received radiation therapy less than four weeks prior to study entry will not be excluded providing the volume of bone marrow treated is less than 10% and that the patient has measurable disease outside the radiation field. Hydroxyurea may be administered to patients with high white cell counts but must be discontinued at least 48 hours prior to the NK-92 cell infusions
- Patients with CNS involvement
- Known HIV, HBV or HCV infection
- Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular events within 3 months of registration, or psychiatric or emotional disorders.
- Patients with hypersensitivity or previous severe reactions to Allopurinol, Acetominophen or Benadryl and all available alternative medications.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00990717
Start Date
March 1 2005
End Date
July 1 2012
Last Update
June 23 2016
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9