BridgeMD
New treatment option for Osteosarcoma
Official title A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma
ClinicalTrials.gov ID: NCT07477457
What this study is testing
What is Methotrexate?
Methotrexate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for osteosarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 49
You may be able to join if
- Cohort 1 only: Newly Diagnosed, Metastatic Osteosarcoma
- For study entry, the suspected diagnosis of osteosarcoma may be based on clinical judgement. Biopsy confirmation is required for treatment but as...
- Having at least 1 extrapulmonary metastasis, radiographic confirmation of metastasis is adequate, and/or
- Unresectable metastases at diagnosis as determined by the investigator
- Patients may have started systemic conventional chemotherapy but must enroll on this study prior to day 29 of chemotherapy initiation. Having...
You likely can't join if
- Cohorts 1 and 2 only:
- Patients who are receiving any other investigational agents for osteosarcoma therapy are ineligible.
- Patient with an uncontrolled chronic or active infection or another condition where any component of OstEvo therapy would be contraindicated.
- Patients with a history of heart disease including, but not limited to: uncontrolled hypertension within 12 months prior to enrollment; ongoing...
- Patients must not be receiving any additional medicines being given for the specific purpose of treating cancer. Alternative medications including...
- Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of oral agents.
See the full eligibility criteria
- Cohort 1 only: Newly Diagnosed, Metastatic Osteosarcoma
- For study entry, the suspected diagnosis of osteosarcoma may be based on clinical judgement. Biopsy confirmation is required for treatment but as this protocol has biologic aims from serial tumor samples, some patients...
- Having at least 1 extrapulmonary metastasis, radiographic confirmation of metastasis is adequate, and/or
- Unresectable metastases at diagnosis as determined by the investigator
- Patients may have started systemic conventional chemotherapy but must enroll on this study prior to day 29 of chemotherapy initiation. Having received a single standard MAP cycle (AP x 1 and HDMTX up to 2 times) of...
- Patients with newly diagnosed osteosarcoma who are not eligible for Cohorts 1 or 2.
- Diagnostic biopsy has insufficient material for research.
- Must be enrolled on MSK IRB 12-245, biospecimen research protocol, with oncologic surgeries planned to be performed at MSK.
- Orthopedic surgeon assessment is that a research biopsy will not increase the risk of local recurrence.
- Patients must be willing to assent, and consenting party must consent to the single research biopsy prior to the initiation of chemotherapy. Patients over 18 must consent to research biopsies at study entry. Cohorts 1...
- Age: Patient must be \> 6 and \< 50 years of age at the time of study enrollment.
- Disease Status: Metastatic high-risk osteosarcoma with cohort specific criteria above
- Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky \> 50 for patients \< 16 years of age within 28 days prior to enrollment.
- Oral Medications: Patients must be able to swallow oral medications as whole tablets/capsule form if a commercially available oral suspension is not available or if tablet dissolution is not stated in the protocol.
- Organ Function Requirements:
- Adequate Hematologic function, defined as: i. Absolute neutrophil count \> 250 cells/mcL ii. Platelet count \> 50,000/mcL b. Adequate Renal Function, defined as: i. May use creatinine clearance (estimated or by cystatin...
- Cohorts 1 and 2 only:
- Patients who are receiving any other investigational agents for osteosarcoma therapy are ineligible.
- Patient with an uncontrolled chronic or active infection or another condition where any component of OstEvo therapy would be contraindicated.
- Patients with a history of heart disease including, but not limited to: uncontrolled hypertension within 12 months prior to enrollment; ongoing cardiac dysrhythmias ≥ grade 2 or atrial fibrillation of any grade...
- Patients must not be receiving any additional medicines being given for the specific purpose of treating cancer. Alternative medications including, but not limited to cannabis-based products would not be a reason for...
- Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of oral agents.
- Patients may not have received prior cardiac irradiation. Cohort 2 only: 5\. Patients must not have previously been enrolled in OstEvo
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.