Decitabine, Cytarabine, GCSF for Refractory AML/MDS

NCT ID: NCT00740181

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-04-30

Brief Summary

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

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.

Conditions

Myelodysplasia; Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

chemotherapy

Intervention Type: DRUG

Interventions

chemotherapy

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Hospital of Rhode Island

OTHER

Sponsor Role: collaborator

Roger Williams Medical Center

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Butera

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Lifespan Hospitals

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

MGI Pharma#DAC 022/2007

Identifier Type: OTHER

Identifier Source: secondary_id

BrUOG-AML-217

Identifier Type: -

Identifier Source: org_study_id