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Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

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ClinicalTrials.gov Identifier: NCT01272245
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : January 9, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of this clinical research study is to learn if omacetaxine given with cytarabine can help to control the disease in patients with AML or high-risk MDS. The safety of the study drugs will also be studied.

Condition or disease Intervention/treatment Phase
Leukemia Drug: Omacetaxine Drug: Cytarabine Phase 2

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Detailed Description:

Study Drugs:

Omacetaxine is designed to block certain proteins, which may cause cancer cells to die.

Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive omacetaxine and cytarabine as an injection under the skin. You will receive instructions on how to give these injections to yourself. You will be given a Research Medication Diary to record the drugs you take each day. You must bring the Research Medication Diary and any unused drugs with you to each study visit. You will also be told how to properly store the drugs.

On Days 1-3 of each cycle, you will give yourself an injection of omacetaxine every 12 hours (+/- 3 hours).

On Days 1-7 of each cycle, you will give yourself an injection of cytarabine every 12 hours (+/- 3 hours).

Each cycle will be 4-7 weeks, depending on how well the disease responds to the study drugs.

Depending on how the disease responds to the study drugs, the number of days you receive your injections may stay the same, increase, or decrease. Your doctor will discuss this with you.

Study Visits:

On Day 1 of each cycle, you will have a physical exam.

Women who are able to become pregnant must have a negative blood (about 1/2 teaspoon) or urine pregnancy test within 3 days before receiving the first dose of study drug.

Blood (about 1 tablespoon) will be drawn every week for routine tests. Once you have a response to treatment, blood will then be drawn every 2-4 weeks while you are receiving treatment. If your doctor thinks it is needed, you may have more blood samples drawn during Cycles 1 and 2.

On Day 21 of Cycle 1 (+/- 7 days), then every 4 weeks after that, you will have a bone marrow aspiration and/or biopsy to check the status of the disease. If the doctor thinks it is needed, these may be done more or less often, depending on your response to treatment.

Length of Study:

You may receive up to 24 cycles of treatment. You will be taken off study early if the disease gets worse or intolerable side effects occur.

Follow-up:

Once you stop taking the study drugs, you will have follow-up for 5 years.

Every 4-8 weeks, blood (about 1 tablespoon) will be drawn for routine tests. If you cannot return to the clinic, you may have blood drawn at a clinic close to your home.

Every 3-6 months, you will be contacted during a clinic visit and asked how you are doing. If you cannot make it to the clinic for this visit, you will be called. The phone call should last about 5 minutes.

This is an investigational study. Omacetaxine is FDA approved to treat patients with certain types of leukemia. Its use in this study is investigational. Cytarabine is FDA approved and commercially available for the treatment of AML. The use of these drugs in combination is investigational.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Omacetaxine (OM) and Low Dose Cytarabine (LDAC) in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Study Start Date : July 2011
Primary Completion Date : January 2017
Study Completion Date : January 2017


Arms and Interventions

Arm Intervention/treatment
Experimental: Omacetaxine and Cytarabine
Omacetaxine 1.25 mg/m2 SQ every 12 hours x 3 days + Cytarabine 20 mg SQ x 7 days of 4-7 week cycle.
Drug: Omacetaxine
1.25 mg/m2 subcutaneously (SQ) every 12 hours (+/- 3 hours) for 3 days (Days 1-3). Each cycle will be 4-7 weeks.
Drug: Cytarabine
20 mg subcutaneously every 12 hours (+/- 3 hours) for 7 days (Days 1-7). Each cycle will be 4-7 weeks.
Other Names:
  • ARA-C
  • Cytosar
  • Depo-Cyt
  • Cytosine Arabinosine Hydrochloride


Outcome Measures

Primary Outcome Measures :
  1. Complete Remission Rate (CR) [ Time Frame: 8 weeks ]
    Complete response (CR) defined as: Peripheral blood counts, no circulating blasts, neutrophil count ≥ 1.0 ×109/L, platelet count ≥ 100 ×109/L, bone marrow aspirate and biopsy, ≤5% blasts, no detectable auer rods, no extramedulary leukemia


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously untreated AML (>/= 20% blasts). Patients with high-risk (intermediate-2 or high by IPSS or ≥10% blasts) MDS will also be eligible. Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed. A single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
  2. Age >/= 60 years.
  3. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
  4. Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) </= 2.5 x ULN) and renal function (creatinine </= 2.0 mg/dL).
  5. Patients must be willing and able to review, understand, and provide written consent before starting therapy.

Exclusion Criteria:

  1. New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure >/= 160 systolic and >/= 110 diastolic not responsive to antihypertensive medication), diabetes mellitus, or congestive heart failure.
  2. Myocardial infarction in the previous 12 weeks (from the start of treatment).
  3. Active and uncontrolled disease/infection as judged by the treating physician.
  4. Pregnancy.
  5. Acute promyelocytic leukemia (APL).
  6. Women of childbearing potential and men who do not practice contraception. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized.
  7. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272245


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cephalon
Investigators
Principal Investigator: Hagop Kantarjian, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01272245     History of Changes
Other Study ID Numbers: 2010-0736
NCI-2013-02220 ( Registry Identifier: NCI CTRP )
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by M.D. Anderson Cancer Center:
Acute Myelogenous Leukemia
AML
High-Risk Myelodysplastic Syndrome
MDS
Omacetaxine
Cytarabine
ARA-C
Cytosar
DepoCyt
Cytosine Arabinosine Hydrochloride

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs