GO-203-2C for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDavid Avigan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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 cancer cells, while leaving healthy cells unaffected.This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies.

Eligibility Criteria

This trial is for adults over 18 with Acute Myeloid Leukemia (AML) that's come back or didn't respond to initial treatment. They should be in decent health otherwise, not pregnant, and willing to use birth control. People with severe heart issues, active infections, recent major surgery, or HIV can't join.

Inclusion Criteria

corrected calcium level ≥ institutional LLN

Negative pregnancy test in women of child-bearing potential

serum bilirubin ≤ 1.5 X institutional ULN OR serum direct bilirubin ≤ 2 X institutional ULN

+12 more

Exclusion Criteria

Unwilling or unable to comply with the requirements of the study protocol

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

+7 more

Participant Groups

The study tests GO-203-2C alone and combined with Decitabine as treatments for AML. It aims to find the safest dose of GO-203-2C and see how well it works against leukemia cells without harming normal cells.

2Treatment groups

Experimental Treatment

Group I: GO-203-2c + DecitabineExperimental Treatment2 Interventions

Dose escalation will occur for GO-203-2c using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. GO-203-2c given daily on predetermined schedule of a 28-day treatment cycle. Decitabine will be administered at a dose of 20mg/m2 on days 8-12 of a 28-day treatment cycle.

Group II: GO-203-2cExperimental Treatment1 Intervention

Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. GO-203-2c given daily on predetermined schedule of a 28-day treatment cycle