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

Conditions

• Metastasis
• Osteosarcoma

Eligibility Criteria

Sex

ALL

Age

6 Years - 49 Years

Healthy Volunteers

Not accepted

Interventions

• Methotrexate — DRUG
  Methotrexate 12 g/m\^2 (max dose 20 grams) intravenously over 4 hours or as per institutional standard.
• Doxorubicin — DRUG
  Doxorubicin 37.5 mg/m\^2 intravenously over 15 to 30 minutes or as per institutional standard.
• Cisplatin — DRUG
  Cisplatin 60 mg/m\^2 intravenously over 4 hours or as per institutional standard.
• Gefitinib — DRUG
  Gefitinib 400 mg/m\^2/dose (maximum dose 250 mg) orally daily for 14 days (14 doses)
• Trametinib — DRUG
  Trametinib will be dispensed as per institutional standard.
• Disulfiram — DRUG
  Disulfiram 250 to 500 mg orally once daily for 14 days
• Sunitinib — DRUG
  Sunitinib capsules for under 18 years of age: 15 mg/m\^2/dose (maximum 50 mg) orally once daily x 14 days
• Ifosfamide — DRUG
  Ifosfamide 2,800 mg/m\^2 intravenously as per institutional standard.
• Biopsy — PROCEDURE
  Research biopsy prior to therapy

Study Details

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.

Key Dates

Start date

Mar 11, 2026

Status verified

Mar 2026

Primary completion

Mar 31, 2028

Completion

Mar 11, 2028

Study Design

Enrollment

45 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Newly Diagnosed, Metastatic Osteosarcoma
  Patient will receive study treatment that includes standard MAP chemotherapy in addition to either gefitinib, trametinib, disulfiram, or sunitinib, or a combination of some of these drugs. Participants will receive the study treatment during 6 treatment Cycles. Each Cycle will last 28 days.
• Experimental: Relapsed, Metastatic Osteosarcoma
  Patient will receive study treatment that includes standard ifosfamide chemotherapy in addition to either gefitinib, trametinib, disulfiram, or sunitinib, or a combination of some of these drugs. Participants will receive the study treatment during 6 treatment Cycles. Each Cycle will last 21 days.
• Experimental: Newly Diagnosed Osteosarcoma
  Research Biopsy only

Primary Outcome Measure

12-month progression free survival (PFS) (cohort 1) [ Time Frame: 12 months ]

Central Contacts

• Damon Reed, MD
  1-833-MSK-KIDS
  [email protected]
• Asmin Tulpule, MD, PhD
  1-833-MSK-KIDS

Locations (7)

Find similar trials in Basking Ridge, NJ

Related Studies

• Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
  Recruiting · Children's Oncology Group · Birmingham, Alabama
• Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
• Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
  PHASE1/PHASE2 · Recruiting · Icahn School of Medicine at Mount Sinai · New York, New York
• Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
  PHASE3 · Recruiting · Children's Oncology Group · Birmingham, Alabama