Status:
ACTIVE_NOT_RECRUITING
A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Acute Myeloid Leukemia, in Relapse
Recurrent Adult Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This research study is studying a targeted therapy known as GO-203-2C as a possible treatment for with acute myeloid leukemia (AML) both alone and in combination with decitabine. GO-203-2c targets can...
Detailed Description
* Phase I * The maximum tolerated dose (MTD) will be determined in the phase I section of the trial. * Patients who fulfill eligibility criteria will be entered into the trial to GO-203-2c. * A...
Eligibility Criteria
Inclusion
- To be considered eligible for enrollment into this study, all of the following inclusion criteria must be met during the screening period:
- Documented AML by peripheral blood and bone marrow analyses meeting WHO criteria, excluding patients with acute promyelocytic leukemia (APL)
- Patients with AML refractory to primary induction chemotherapy, relapsed disease, or age ≥ 60 and not appropriate for standard cytotoxic therapy due to age, performance status, and/or adverse risk factors according to the treating physician
- Age ≥ 18 years
- Karnofsky performance status ≥ 50% or ECOG performance status 0-2
- Life expectancy ≥ 6 weeks
- Able to understand the investigational nature of this study and to provide written consent to participate in it
- Signed written IRB-approved Informed Consent document
- Adequate hepatic and renal function:
- serum bilirubin ≤ 1.5 X institutional ULN OR serum direct bilirubin ≤ 2 X institutional ULN
- serum ALT and AST ≤ 2.5 X institutional ULN
- serum alkaline phosphatase \< 5 X institutional ULN
- serum creatinine ≤ 2.0 mg/dL
- corrected calcium level ≥ institutional LLN
- Negative pregnancy test in women of child-bearing potential
- Women and men of child-producing potential must agree to use effective contraceptive methods during the study period (including post-treatment observation period)
Exclusion
- A patient will be considered not eligible for enrollment into this study if any of the following criteria are met during the screening period:
- Evidence of leukemic meningitis or other CNS involvement by leukemia
- Uncontrolled or poorly controlled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg) Note: an isolated reading that is not sustained will be permitted.
- Evidence of NYHA Class III or IV cardiac disease, or presence of unstable life-threatening arrhythmia, or history of myocardial infarction during the past 6 months
- Active bacterial, fungal, or viral infection requiring systemic treatment
- Known infection with HIV
- History or major surgery within 4 weeks before the first dose of study treatment, or not recovered from prior surgery
- Exposure to any other investigational agent at any time within 4 weeks before the first dose of study treatment
- Exposure to any other anti-leukemic therapy (except hydroxyurea, see Section 5.5.1) within 2 weeks before the first dose of study treatment
- Pregnant or lactating female
- Unwilling or unable to comply with the requirements of the study protocol
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02204085
Start Date
September 1 2014
End Date
December 1 2025
Last Update
January 24 2025
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215