DFMO for Bone Cancer
(DFMO Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAlice Lee, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Montefiore Medical Center

No Placebo Group

Trial Summary

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.

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.

+3 more

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.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Treatment with DFMOExperimental Treatment1 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.