Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
An Open Label, Dose-Escalation Study to Evaluate Safety, Tolerability, Maximum Tolerated Dose (MTD), Efficacy, and Pharmacokinetics (PKs) of CPI-613 Given With High Dose Cytarabine and Mitoxantrone in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Verified date | June 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I trial studies the side effects and best dose of CPI-613 when given together with cytarabine and mitoxantrone hydrochloride in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as CPI-613, cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. CPI-613 may help cytarabine and mitoxantrone hydrochloride work better by making cancer cells more sensitive to the drugs
Status | Completed |
Enrollment | 67 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must have histologically or cytologically documented relapsed and/or refractory acute myeloid leukemia - Eastern Cooperative Oncology Group (ECOG) performance status of = 3 - Expected survival > 3 months - Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation; (Note: Pregnant patients are excluded because the effects of CPI-613 on a fetus are unknown) - Fertile men must practice effective contraceptive methods during the study period, unless documentation of infertility exists - Mentally competent, ability to understand and willingness to sign the informed consent form - No radiotherapy, treatment with cytotoxic agents (except CPI-613), treatment with biologic agents or any anti-cancer therapy within the 2 weeks prior to treatment with CPI-613; patients must have fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment); patients with persisting, non-hematologic, non-infectious toxicities from prior treatment = grade 2 are eligible, but must be documented as such - Aspartate aminotransferase ([AST]/serum glutamic oxaloacetic transaminase [SGOT]) =< 3 x upper normal limit (UNL), alanine aminotransferase ([ALT]/serum glutamate pyruvate transaminase [SGPT]) =< 3 x UNL (=< 5 x upper limit of normal [ULN] if liver metastases present) - Bilirubin =< 1.5 x UNL - Serum creatinine =< 1.5 mg/dL or 133 µmol/L - International Normalized Ratio or INR must be < 1.5 Exclusion Criteria: - Serious medical illness, such as significant cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, pericardial disease or New York Heart Association class III or IV), or severe debilitating pulmonary disease, that would potentially increase patients' risk for toxicity - Patients with active central nervous system (CNS) or epidural tumor - Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease) - Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown) - Lactating females because the potential of excretion of CPI-613 into breast milk (Note: Lactating females are excluded because the effects of CPI-613 on a nursing child are unknown) - Fertile men unwilling to practice contraceptive methods during the study period - Life expectancy less than 3 months - Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients - Unwilling or unable to follow protocol requirements - Patients with large and recurrent pleural or peritoneal effusions requiring frequent drainage (e.g. weekly); patients with any amount of clinically significant pericardial effusion - Active heart disease including myocardial infarction within previous 6 months, symptomatic coronary artery disease, uncontrolled arrhythmias, or symptomatic congestive heart failure - Albumin < 2.0 g/dL or < 20 g/L - Evidence of ongoing, uncontrolled infection - Patients with known human immunodeficiency virus (HIV) infection; (Note: Patients with known HIV infection are excluded because patients with an immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, and because there may be unknown or dangerous drug interactions between CPI-613 and anti-retroviral agents used to treat HIV infections) - Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment (the use of Hydrea is allowed) - Patients who have received immunotherapy of any type within the past 4 weeks prior to initiation of CPI-613 treatment - Requirement for immediate palliative treatment of any kind including surgery - Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months - A history of additional risk factors for torsade de pointes (e.g., clinically significant heart failure, hypokalemia, family history of long QT syndrome) |
Country | Name | City | State |
---|---|---|---|
United States | Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MTD of CPI-613 based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 3.0) | 14 days | ||
Secondary | Response rate (CR, CRi, and PR) | Confidence intervals will be calculated. | Day 14 of course 1 | |
Secondary | Overall survival | We will use Kaplan-Meier estimation. | Up to 6 months |
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