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Tests treatment safety and results for Sarcoma
Official title Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
ClinicalTrials.gov ID: NCT07125183
What this study is testing
What is Doxorubicin?
Doxorubicin is an investigational medicine, given as an once-weekly, being studied as a potential treatment for sarcoma.
Also referred to as Lipodox, Lipodox 50.
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 overall goal of this Phase 2 study is to determine the efficacy of a lower dose weekly schedule of doxorubicin in patients with unresectable leiomyosarcomas aged 65-100 years old. While doxorubicin is the standard of care therapy for sarcomas not removable by surgery, older or more frail patients may struggle to tolerate side effects of the treatment including immune cell suppression.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 100
You may be able to join if
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be male or female aged 65-100 years at the time of signing informed consent.
- Have a histological diagnosis of advanced or metastatic soft tissue leiomyosarcoma (LMS) (by local pathology review), not curable by surgery, for...
- Have measurable or non-measurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors. Tumors within a previously...
You likely can't join if
- Prior therapy with anthracycline.
- Hypersensitivity to doxorubicin or any excipients.
- Patients may not be receiving any other investigational agents (within 28 days prior to Cycle 1, Day 1).
- Patient has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 21 days prior to Cycle 1, Day 1 or has not recovered...
- Additional known malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, or squamous cell...
- Patients with underlying immune deficiency, chronic infections including hepatitis, and known history of HIV or tuberculosis (TB).
See the full eligibility criteria
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be male or female aged 65-100 years at the time of signing informed consent.
- Have a histological diagnosis of advanced or metastatic soft tissue leiomyosarcoma (LMS) (by local pathology review), not curable by surgery, for which treatment with weekly doxorubicin is deemed appropriate by the...
- Have measurable or non-measurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors. Tumors within a previously irradiated field will be designated as "nontarget" lesions unless...
- Have received 0 to 4 prior systemic therapies for metastatic sarcoma and NO prior anthracyclines. Re-treatment with the same drug or regimen after interruption (i.e. chemotherapy holiday) is not considered a new line of...
- Adequate organ function
- ECOG performance status of 0, 1 or 2.
- Patients must consent and be willing to undergo tumor core needle biopsies at two time points: 1. Baseline, 2. Cycle 2 Day 1 (+/- 7 days); a third biopsy for off-study/progression is optional but advised. At least one...
- Male people should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Prior history of vasectomy does NOT replace...
- Female people will be post-menopausal as evidenced by cessation of menses for a minimum of 2 years. Prior hysterectomy or bilateral oophorectomy is also permissible.
- people must either possess or undergo placement of central venous catheter, including pheresis or trifusion catheter, PICC line, or port.
- Prior therapy with anthracycline.
- Hypersensitivity to doxorubicin or any excipients.
- Patients may not be receiving any other investigational agents (within 28 days prior to Cycle 1, Day 1).
- Patient has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 21 days prior to Cycle 1, Day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents...
- Additional known malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy...
- Patients with underlying immune deficiency, chronic infections including hepatitis, and known history of HIV or tuberculosis (TB).
- Patients with underlying hematologic issues including bleeding diathesis, such as known previous GI bleeding requiring intervention within the past 6 months. Newly diagnosed pulmonary emboli or deep venous thrombosis...
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease. people with previously treated brain metastases may participate provided they are stable based on the...
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines...
- Any uncontrolled, intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
- Prolonged QTc interval on Screening EKG \>475 ms.
- Left Ventricular Ejection Fraction \<50% by 2D ECHO or MUGA scan at Screening.
- Any serious medical or psychiatric illness/condition including substance use disorders likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment, including NYHA...
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, 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, 65 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, 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.