A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)
Study Details
Study Description
Brief Summary
This is a phase 1 study (the first stage in testing a new treatment to see how safe and tolerable the treatment is) which will include patients with acute myeloid leukemia (AML) that has either returned or has a more than a 70% chance of coming back and cannot have a bone marrow transplant.
This study will see whether modifying a patient's AML cells to produce IL-12 and giving it back to the patient is safe and useful in patients with AML that cannot have bone marrow transplants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IL-12 A single dose of IL-12, given intravenously. |
Biological: IL-12
|
Outcome Measures
Primary Outcome Measures
- Number of side effects by type and severity [2 years]
Secondary Outcome Measures
- Levels of IL-12 [1 day]
- Levels of acute myeloid leukemia (AML) [1 day]
- Length of time patient is alive [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient with AML and >=18 years of age.
-
Agrees to participate in the study and signs the informed consent
-
Viable cells are available for successful modification
-
First or higher complete remission and have high risk features of relapse.
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Patients who have received prior treatment and are not in remission must have stable white blood cell count and are not receiving any chemotherapy or desiring further intensive treatment.
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Less than 10% blast cells in the bone marrow following induction or re-induction therapy and not desiring further intensive treatment.
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Acceptable creatinine, Aspartate transaminase (AST), Alkaline phosphatase (ALP), bilirubin lab results.
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Agree to use contraception
-
Not pregnant
-
Able to comply with study procedures
Exclusion Criteria:
-
Eastern Cooperative Oncology Group (ECOG) performance status >2
-
Known persistent infection
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Known central nervous system (CNS) disease
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Greater than 10% blasts in the bone marrow or circulating blast cells
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Life expectancy < 2 months
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Receiving any chemotherapy, corticosteroids, Cox2 inhibitors or any non-drug therapies with the intent of altering the immune response or kill leukemic cells within one week prior to infusion of IL-12, except azacytidine.
-
Patients who are HIV positive.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Princess Margaret Centre Centre | Toronto | Ontario | Canada | M5G 2M9 |
Sponsors and Collaborators
- University Health Network, Toronto
- Ozmosis Research Inc.
Investigators
- Principal Investigator: Mark Minden, M.D., Princess Margaret Cancer Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DDP-IL-12
- OZM-068