A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma

Summary

The researchers are doing this study to find out whether adding gefitinib, trametinib, disulfiram, and sunitinib to standard chemotherapy is a more effective treatment approach for people with osteosarcoma than standard chemotherapy on its own. The researchers will also look at the safety of adding these drugs to standard chemotherapy. The researchers will also use the additional research biopsies from Cohort 1 participants to learn more about how osteosarcoma survives during chemotherapy.

Conditions

• Osteosarcoma
• Metastasis

Interventions

DRUG

Methotrexate

Methotrexate 12 g/m\^2 (max dose 20 grams) intravenously over 4 hours or as per institutional standard.

DRUG

Doxorubicin

Doxorubicin 37.5 mg/m\^2 intravenously over 15 to 30 minutes or as per institutional standard.

DRUG

Cisplatin

Cisplatin 60 mg/m\^2 intravenously over 4 hours or as per institutional standard.

DRUG

Gefitinib

Gefitinib 400 mg/m\^2/dose (maximum dose 250 mg) orally daily for 14 days (14 doses)

DRUG

Trametinib

Trametinib will be dispensed as per institutional standard.

DRUG

Disulfiram

Disulfiram 250 to 500 mg orally once daily for 14 days

DRUG

Sunitinib

Sunitinib capsules for under 18 years of age: 15 mg/m\^2/dose (maximum 50 mg) orally once daily x 14 days

DRUG

Ifosfamide

Ifosfamide 2,800 mg/m\^2 intravenously as per institutional standard.

PROCEDURE

Biopsy

Research biopsy prior to therapy

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Damon Reed, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-11

Primary Completion

2028-03-31

Completion

2028-03-11

FDA Drug

Yes

Countries

• United States

Study Locations