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Cancer Vaccine

GO-203-2C for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Led By David Avigan, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is testing a new targeted therapy for AML patients. The therapy, GO-203-2C, is being tested both alone and in combination with decitabine. This is a Phase I/II clinical trial, which means they are testing both the safety and effectiveness of the new therapy.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include reactions specific to where the drug acts on cancer cells but may also affect normal cell function leading to blood count changes, fatigue, digestive issues or potential liver and kidney-related symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose of GO-203-2c
Maximum Tolerated Dose of GO-203-2c in combination with decitabine
Secondary study objectives
To determine if therapy GO-203-2c in combination with decitabine results in at least 20% of patients achieving a clinical response

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GO-203-2c
2011
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER
1,100 Previous Clinical Trials
353,064 Total Patients Enrolled
Beth Israel Deaconess Medical CenterLead Sponsor
848 Previous Clinical Trials
12,930,071 Total Patients Enrolled
David Avigan, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
14 Previous Clinical Trials
426 Total Patients Enrolled

Media Library

GO-203-2c (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02204085 — Phase 1 & 2
~3 spots leftby Sep 2025
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