Overview

This trial is active, not recruiting.

Condition leukemia
Treatments e7070, idarubicin, cytarabine, dexamethasone
Phase phase 2
Sponsor M.D. Anderson Cancer Center
Collaborator Eisai Inc.
Start date February 2013
End date February 2019
Trial size 40 participants
Trial identifier NCT01692197, 2009-0570, NCI-2012-02065

Summary

The goal of this clinical research study is to learn if E7070 in combination with idarubicin, cytarabine, and dexamethasone can help to control the disease in patients with either AML or high-risk MDS that has relapsed. The safety of the drug combination will also be studied.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Stage 1: E7070 400 mg/m2 by vein (IV) over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only). If at assessment participant found to be in CR, CRp, PR or marrow clearance of blasts, they may receive post-remission therapy with E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) every 3 weeks for up to five additional cycles as long as clinical benefit continues.
e7070
400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.
(Experimental)
Stage 2: E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age > 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.
e7070
400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.
idarubicin Idamycin
8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).
cytarabine ARA-C
1.0 g/m2 by vein daily on Days 9 - 12 (age <60 years) or Days 9 - 11 (age > 60 years).
dexamethasone Decadron
10 mg by vein daily for 3 - 4 days with cytarabine.

Primary Outcomes

Measure
Overall Response
time frame: 21 days
Toxicity Profile
time frame: 28 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. All patients with histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (AML) [except acute promyelocytic leukemia], or high-risk myelodysplastic syndrome (HRMDS) (Int-2 high risk by IPSS or >10% blasts in marrow). 2. Patients must be 18 years or older. 3. Patients must have a performance status of 0-2 (Zubrod scale). 4. Patients must have adequate renal function (serum creatinine less than or equal to 1.3 mg/dL and/or creatinine clearance > 40 mL/min). Patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the Principal Investigator (PI) (up to creatinine less than or equal to 2.0), and appropriate dose adjustments will be considered. 5. Patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; SGOT or SGPT less than or equal to 3X the ULN for the reference lab unless due to leukemia or congenital hemolytic disorder or bilirubin). Patients with hepatic dysfunction (SGOT/SGPT up to less than or equal to 5 X ULN) due to organ infiltration by disease may be eligible after discussion with the PI, and appropriate dose adjustments will be considered. 6. Patients must have normal cardiac ejection fraction 7. QTc interval

Additional Information

Official title A Phase 2 Study of E7070, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes
Principal investigator Gautam Borthakur, MBBS
Description The Study Drugs: E7070 is designed to stop metabolic ingredients from reaching the cancer cells and to stop the cancer cell from dividing. Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself. Idarubicin is designed to cause breaks in both strands of DNA (the genetic material of cells). Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to AML patients in combination with other chemotherapy to treat cancer. Study Drug Administration: If you are found eligible to take part in this study, you will receive E7070 by vein over 1 hour on Day 1 and Day 8 (+/- 2 days on Day 8 only) followed by idarubicin by vein over 1 hour on Days 9-11. You will also receive cytarabine by vein over 24 hours each day on Days 9-12. If you are 60 years of age or older, you will only receive cytarabine on Days 9-11. On days that you are receiving the cytarabine infusions, you will also receive dexamethasone by vein over about 30 minutes. You will receive dexamethasone before the cytarabine infusions. Each study cycle is about 28 days. If your doctor thinks you are benefitting from taking the E7070 in combination with idarubicin, cytarabine, and dexamethasone, you may receive up to 2 additional cycles of the study drug combination. Study Visits: During Cycle 1, the following tests and procedures will be performed: - You will be asked about medications you are taking and side effects you may have had. - Blood (about 2 teaspoons) will be drawn at least 1 time every week for routine tests and to check your liver and kidney function. - You will have a bone marrow aspirate on Day 28 (+/- 3 days) to check the status of the disease. You may have additional bone marrow aspirates during Cycle 2 if the doctor thinks it is necessary. - During Cycle 1 only, you will have an ECG on Day 2 (+/- 1 day) and Day 8 (+/- 2 days). Treatment cycles beyond Cycle 1, the following tests and procedures will be performed: - You will be asked about medications you are taking and side effects you may have had. - Blood (about 2 teaspoons) will be drawn every 2-4 weeks for routine tests. - You will have a bone marrow aspirate to check the status of the disease whenever the doctor feels it is necessary. Length of Study: If the doctor thinks you are benefitting with E7070 in combination with idarubicin, cytarabine and dexamethasone, you may receive 2 additional cycles of therapy (a total of 3 cycles on this study.) You will be taken off study if the disease gets worse, you experience intolerable side effects, or if the study doctor thinks it is in your best interest. End-of-Treatment Visit: At the end of treatment, blood (about 2 teaspoons) will be drawn for routine tests within 30 days (+/- 5 days) of your last dose of the study drug combination. You will also be asked about any side effects you may have had. Long Term Follow-up (unless you have started on alternative therapy): Blood (about 1 tablespoon) will be drawn for routine tests every 2-3 months for up to 2 years unless the disease gets worse or you start on another treatment. This is an investigational study. E7070 is not FDA-approved or commercially available for use in patients with AML or MDS that has relapsed. Its use in this study is considered investigational. Idarubicin, cytarabine, and dexamethasone are FDA-approved and commercially available for use in the treatment of AML. The combination of E7070, idarubicin, cytarabine, and dexamethasone in this study is investigational. Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.