DFMO for Bone Cancer

(DFMO Trial)

Overseen By Rebecca Zylber, MSN

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Montefiore Medical Center

Disqualifiers: Pregnancy, Uncontrolled infection, Illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

15 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

The purpose of this study is to determine the feasibility of administering DFMO to patients with relapsed Ewing sarcoma and osteosarcoma who have completed all planned therapy and have no evidence of disease.

Research Team

Alice Lee, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

This trial is for patients who have experienced a relapse of Ewing Sarcoma or Osteosarcoma, which are types of bone cancer. Participants should have completed all planned therapy and currently show no signs of the disease.

Inclusion Criteria

I am younger than 40 years old.

I have completed all treatments for my relapsed bone cancer and currently show no signs of the disease.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I do not have any infections that aren't responding to treatment.

I have a serious illness besides cancer.

I am not pregnant or breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

DFMO is administered orally every 12 hours in 28-day cycles at FDA approved dosages based on body surface area

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DFMO

Trial Overview The study is testing the feasibility of using DFMO, a drug, as maintenance therapy for those who've had Ewing Sarcoma or Osteosarcoma but are now in remission after completing their initial treatment.

Participant Groups

Group I: Treatment with DFMO Experimental Treatment 1 Intervention

DFMO will be administered orally every 12 hours in 28-day cycles at the FDA approved dosages based on the patient's body surface area (BSA). DFMO tablets are 192 mg. * Patients with a BSA \< 1.5 m2 will take 768 mg (four tablets) orally twice a day. * Patients with a BSA 0.75 to 1.5 m2 will take 576 mg (three tablets) orally twice a day. * Patients with a BSA of 0.5 to \< 0.75 m2 will take 384 mg (two tablets) orally twice a day. * Patients with a BSA of 0.25 to \< 0.5 m2 will take 192 mg (one tablet) orally twice a day.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+