Acute Myelogenous Leukemia Clinical Trial
Official title:
Open Label, Phase II Dosing Study of Ara-C Chemotherapy in Combination With EL625 and Idarubicin in Refractory and Relapsed Acute Myelogenous Leukemia (AML)
Verified date | September 2014 |
Source | Eleos, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The principal goal of this clinical trial is to assess the ability of cenersen sodium
(EL625) to improve cancer responsiveness to the established AML therapeutic agent Idarubicin
used alone or in combination with Cytarabine (Ara-C).
Cenersen sodium is a drug that is designed to block the effects of a protein called p53.
Laboratory evidence shows that blocking p53 will make many types of cancer, including acute
myelogenous leukemia (AML), more sensitive to a variety of established cancer therapeutics
while making normal tissues more resistant to the toxic effects of these agents.
Status | Completed |
Enrollment | 53 |
Est. completion date | May 2007 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria - Subjects with either refractory AML (not achieving a CR after a single course of induction), or relapsed AML that have a CR for less than one year. - greater or equal to 18 years old. - Life expectancy of more than 4 weeks following initiation of treatment. - Performance status (Zubrod) less or equal to 3. - Total Bilirubin less or equal to 1.5 x upper normal limit (UNL) unless attributable to organ infiltration by leukemia, and ALT(SGPT) less or equal to 2.5 x UNL. - Creatinine less or equal to 1.5 x UNL unless attributable to organ infiltration by leukemia. - If plasma creatinine value is borderline, creatinine clearance greater or equal to 60 ml/min (actual or calculated), serum magnesium should be within the normal value. - Subjects with liver and/or renal dysfunction due to organ infiltration by leukemia are eligible. - Left Ventricular Ejection Volume (LVEF) of >50% as determined by multi-gated acquisition scan (MUGA) or echocardiogram. - Able to comply with scheduled follow-up and with management of toxicity. - Sexually active patients must use an effective method of contraception during the study dosing period. The following are considered acceptable methods of contraception: (i) oral contraceptive pill, (ii) condom, (iii) diaphragm plus spermicide, (iv) patient or partner surgically sterile, (v) patient or partner more than 2 years post-menopausal or (vi) injectable or implantable agent/device. - Informed consent form obtained, signed and dated prior to initiation of treatment Exclusion Criteria: - Subjects with M3 AML. - Subjects receiving other anti-leukemia investigational agents (i.e., unapproved drugs). However, individual cases will be considered on a case-by-case basis for other investigational agents (e.g., antibiotics, antifungals). - Pregnant or lactating subjects. Chemotherapy (including hydroxyurea) within three (3) weeks prior to initiation of therapy, unless there is evidence of rapidly progressive disease; then subjects may be enrolled with a minimum of two (2) weeks from previous treatments. Prohibited Medications during the first week of each course: - Acetaminophen - Hi-Dose antioxidants (e.g., Vitamins C, E; Multivitamins) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | M. D. Anderson Cancer Center | Houston | Texas |
United States | University of California, San Diego | La Jolla | California |
United States | North Shore University Hospital | Lake Success | New York |
United States | University of Miami Health Center | Miami | Florida |
United States | Washington University Medical Center (Siteman Cancer Center) | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Eleos, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the effective dose of Cytarabine chemotherapy to be used in combination with EL625 and Idarubicin. | Cenersen plus standard of care | 6 months | Yes |
Secondary | Determine the safety profile for the combination of EL625 and Idarubicin +/- Cytarabine. | Standard of care plus cenersen | 6 months | Yes |
Secondary | Determine the Complete Response Rate and Time to Progression. | Standard of care plus cenersen | 6 months | No |
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