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New treatment option for Leiomyosarcoma
Official title A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions
ClinicalTrials.gov ID: NCT06308419
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for leiomyosarcoma.
Also referred to as Gemcitabine Hydrochloride, Gemzar®.
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
- To find a recommended dose of gemcitabine and nab-sirolimus that can be given in combination to participants with advanced leiomyosarcomas or soft-tissue sarcomas.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically confirmed leiomyosarcoma or sarcoma with TSC2 or TSC1 loss-of-function mutations or deletions based on...
- Sarcoma that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. One prior standard...
- Prior gemcitabine-based chemotherapy is allowed if the last dose of gemcitabine was given more than 12 months prior to the first dose of treatment on...
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to...
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of nab-sirolimus in combination with gemcitabine in...
See the full eligibility criteria
- Patients must have histologically confirmed leiomyosarcoma or sarcoma with TSC2 or TSC1 loss-of-function mutations or deletions based on standard-of-care genomic testing.
- Sarcoma that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. One prior standard systemic therapy is required for leiomyosarcoma (LMS) Patients.
- Prior gemcitabine-based chemotherapy is allowed if the last dose of gemcitabine was given more than 12 months prior to the first dose of treatment on trial, there was no progression of disease while on treatment with...
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as...
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of nab-sirolimus in combination with gemcitabine in patients \<18 years of age, children are excluded from this study.
- ECOG performance status ≤2 (Karnofsky ≥60%,).
- Life expectancy of \>3 months, as determined by the investigator.
- Patients must have adequate organ and marrow function as defined below: i. absolute neutrophil count ≥1,500/mcL ii. platelets ≥100,000/mcL iii. hemoglobin ≥9 gm/dL iv. total bilirubin ≤ 2 x institutional upper limit of...
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For Participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
- Patients with Human Immunodeficiency Virus (HIV) with a viral load \<400copies/mL, no IADS-defining illness within 12 months of enrollment, and no CYP3A4 inducers or inhibitors in the antiretroviral treatment.
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- The effects of nab-sirolimus on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control...
- Ability to understand and the willingness to sign a written informed consent document. Exclusion:
- Patients who are receiving any other investigational agents or have received any other investigational agent within 3 weeks prior to enrollment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-sirolimus or gemcitabine.
- Use of strong inhibitors and inducers of CYP3A4 within the 7 days prior to receiving the first dose of nab-sirolimus. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl...
- Patients with active concurrent malignancy.
- Recent stroke or thromboembolic event (within 6 months) requiring anticoagulation that cannot be interrupted. Non-life threatening deep venous thrombosis on stable anticoagulation within 6 months is allowed.
- Active gastro-intestinal bleeding.
- Pre-existing thyroid abnormality is allowed provided thyroid can be controlled with medication.
- Prior treatment with radiotherapy (including radio-labeled spheres and/or cyberknife, hepatic arterial embolization (with or without chemotherapy) or cyrotherapy/ablation) is allowed if these therapies did not affect...
- Uncontrolled diabetes mellitus as defined by HbA1c \>8% despite adequate therapy.
- Evidence of severe or uncontrolled systemic disease or any other concurrent condition, including psychiatric, that would significantly limit the ability to participate safely in this study.
- Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nab-sirolimus, breastfeeding should be...
- Prior treatment of sarcoma with mTOR inhibitors.
- Vulnerable populations will not be enrolled.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.