200 Participants Needed

Plasma Collection for Leiomyosarcoma

Recruiting at 10 trial locations
SS
Overseen ByScott Schuetze
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan Rogel Cancer Center
Must be taking: Doxorubicin, Gemcitabine/Docetaxel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify early blood markers that indicate the effectiveness of chemotherapy for individuals with metastatic leiomyosarcoma, a cancer originating in smooth muscles that can spread. Researchers will examine changes in circulating tumor DNA (tiny bits of tumor DNA in the blood) to predict the cancer's response to treatment. Participants must provide blood samples through plasma collection and may also provide tumor tissue for further analysis. The trial seeks patients with leiomyosarcoma that cannot be surgically removed or has spread, who are beginning chemotherapy with drugs such as doxorubicin or gemcitabine/docetaxel.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves chemotherapy, it's important to discuss your current medications with the trial team to ensure there are no interactions.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on identifying biomarkers for metastatic leiomyosarcoma, a rare and aggressive cancer. Unlike traditional treatments that primarily involve surgery, chemotherapy, or radiation, this trial aims to enhance our understanding of the disease by analyzing plasma and tumor samples. By identifying specific biomarkers, researchers hope to pave the way for more personalized and effective treatment options in the future, potentially improving outcomes for patients with this challenging condition.

Who Is on the Research Team?

SS

Scott Schuetze

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement
Receiving first-line chemotherapy with doxorubicin or gemcitabine/docetaxel
Sum of target lesions per RECIST1.1 of 5 cm or greater
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive chemotherapy with blood samples collected for ctDNA analysis and tumor tissue analysis

54 months
Blood collections at baseline, optional day 8 of cycle 1, day 1 of cycles 2-6 and at progression

Follow-up

Participants are monitored for safety and effectiveness after treatment, with analysis of ctDNA and tumor response

4 years

What Are the Treatments Tested in This Trial?

Interventions

  • Plasma Collection
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Enrolled SubjectsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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