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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

Study 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.

Eligible Conditions

Acute Myeloid Leukemia (AML) in Relapse
Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose of GO-203-2c

Maximum Tolerated Dose of GO-203-2c in combination with decitabine

Secondary outcome measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

To assess whether in vitro response to GO-203-2c alone and in combination with decitabine is associated with clinical response

To determine if therapy GO-203-2c in combination with decitabine results in at least 20% of patients achieving a clinical response

+2 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER

1,079 Previous Clinical Trials

340,915 Total Patients Enrolled

Beth Israel Deaconess Medical CenterLead Sponsor

836 Previous Clinical Trials

13,010,197 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity for participants in this medical experiment?

"Currently, this research project is not in need of participants. The study was first posted on September 1st 2014 and last modified on January 25th 2022. Alternatively, a plethora of other trials are actively recruiting; 1463 for leukemia sufferers and 102 specifically related to GO-203-2c intervention."

Answered by AI

What therapeutic benefits has GO-203-2c been proven to provide?

"GO-203-2c is indicated for the treatment of intermediate-risk myelodysplastic syndromes (MDS) and can also be employed to tackle refractory anemias, high risk MDS, as well as anaemia."

Answered by AI

Is there availability to participate in this scientific trial?

"According to clinicaltrials.gov, this trial is not presently looking for participants, having been initially posted on the 1st of September 2014 and most recently updated on the 25th January 2022. However, there are still 1565 different medical investigations that remain open for recruitment at present."

Answered by AI

What past research has been done to investigate the effects of GO-203-2c?

"At present, 102 studies are ongoing which involve GO-203-2c with 15 trials in Phase 3. Primarily based out of Philadelphia, Pennsylvania, these investigations have encompassed 1483 sites across the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia

David Avigan 2014. "A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02204085.

All > Acute Myeloid Leukemia > Aml