Decitabine, Cytarabine, GCSF for Refractory AML/MDS

This study has been terminated.
(Lack of efficacy)
Sponsor:
Collaborators:
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Information provided by (Responsible Party):
James Butera, Brown University
ClinicalTrials.gov Identifier:
NCT00740181
First received: August 21, 2008
Last updated: July 27, 2014
Last verified: July 2014
  Purpose

This study will determine the activity of decitabine, low dose cytarabine (ARA-C) and G-CSF for patients with myelodysplasia and leukemia.


Condition Intervention Phase
Myelodysplasia
Leukemia
Drug: chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study With Decitabine, Low Dose Cytarabine and G-CSF in High-risk Myelodysplastic Syndromes, Refractory Acute Myeloid Leukemia or Acute Myeloid Leukemia in Patients With Significant Co-morbidities.

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Response Rate [ Time Frame: within 30 days of last treatment ] [ Designated as safety issue: No ]

    Complete Response/Complete Remission:

    Complete remission (CR) is defined as the presence of all of the following:

    • Peripheral blood - No leukemic blasts present.
    • No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)
    • Bone marrow
    • No Auer rods
    • Less than 5% blast cells.
    • CBC and bone marrow criteria must be met within one week of each other.
    • Hemoglobin 9g/dl or greater
    • Neutrophil count >1000 and platelet count >100,000.
    • RBC Transfusion free for 2 weeks.


Enrollment: 9
Study Start Date: August 2008
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy
Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
Drug: chemotherapy

Detailed Description:

The primary objective of this study is to determine the feasibility and toxicity of decitabine, ARA-C and G-CSF for patients with myelodysplasia, refractory acute leukemia and poor performance status acute leukemia.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must have histological confirmation of disease prior to enrollment on study.
  • Patients with de novo AML who are not eligible for induction chemotherapy are eligible. Patients with refractory, relapsed AML are eligible.
  • Patients with AML evolving from prior MDS or secondary to prior chemotherapy are eligible provided they are not eligible for standard induction chemotherapy.
  • Patients with MDS and with blasts > 10% (RAEB-II) are eligible.
  • Patients with extramedullary relapse only (i.e., leukemia cutis or other extramedullary site) are eligible as long as disease can be monitored.
  • Patients who have relapsed after standard autologous and/or allogeneic bone marrow transplant are eligible as long as they meet all other eligibility criteria.
  • Patients must not have had any chemotherapy, except hydrea, or radiation for at least 4 weeks prior.
  • Patients must be > 18 years of age.
  • Patients with an active second malignancy other than non-melanoma skin cancers are not eligible.
  • Patients must have an expected life expectancy of > 12 weeks at the time of enrollment.
  • Patients with visceral, blood stream or nervous system opportunistic infection are eligible if the infection has been appropriately treated and controlled. Patients with fungal lung infections must have had treatment for at least one month and have proof of regression prior to enrollment. Patients may be on antimicrobials at the time of therapy.
  • Initial required laboratory values:

    • Total Bilirubin < 2 X upper limit of normal.
    • AST & ALT < 3 X upper limit of normal (if elevated liver enzymes thought likely due to Leukemic infiltrate discuss with the Principal Investigator and the BrUOG Central Office).
    • Creatinine < 2 mg/dl.
    • < 15,000 K/uI blast count—Hydroxyurea can be used to decrease count if more than 15,000 K/ul.
  • Patients must have an ECOG performance status of 0-2.
  • Patients must receive and sign a full informed consent.
  • Patients should not have co-existing medical illnesses which would limit survival < 12 weeks.
  • No known history of HIV.
  • The safety of decitabine in human pregnancy is unknown. Based on animal studies, decitabine may cause fetal harm when administered to a pregnant woman. Therefore, it is important that you do not become pregnant or father a child while receiving study medication and for 2 months afterwards because the drugs in this study may affect an unborn baby.
  • If you are a woman capable of becoming pregnant (not surgically sterile or post-menopausal), you must have a negative pregnancy test before beginning treatment.

If you do become pregnant, suspect you are pregnant, or if your partner becomes pregnant while you are on this study, you must notify your study doctor immediately. If you become pregnant, you will be taken off this study.

In addition, you must not breast feed at any time you are on this study since any drugs you are taking may also affect the child.

If you are capable of giving birth to or fathering a child, you must agree to use a form of birth control (examples of effective birth control are: a condom or a diaphragm with spermicidal jelly; oral, injectable, or implanted birth control; or abstinence) that is medically acceptable to your study doctor while taking part in this research study.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740181

Locations
United States, Rhode Island
Lifespan Hospitals
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Investigators
Principal Investigator: James Butera Brown University
  More Information

No publications provided

Responsible Party: James Butera, Prinicipal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00740181     History of Changes
Other Study ID Numbers: BrUOG-AML-217, MGI Pharma#DAC 022/2007
Study First Received: August 21, 2008
Results First Received: May 14, 2013
Last Updated: July 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
myelodysplasia
refractory leukemia
acute leukemia

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

ClinicalTrials.gov processed this record on August 26, 2014