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Anti-tumor antibiotic

Combination Therapy for Soft Tissue Sarcoma

Phase 1 & 2

Recruiting

Led By Jessica Gartrell, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with CIC-DUX 4 rearranged sarcomas will be enrolled on the high-risk stratum only, regardless of presence of metastasis, size, or resection status.

Patient must have adequate organ function in the organs that will be within the radiotherapy field.

Must not have

Patients with known primary CNS sarcoma or CNS metastases are not eligible.

Patients with conditions affecting CYP3A4 metabolism, gastrointestinal absorption, thyroid replacement therapy, gastrointestinal bleeding or perforation, pulmonary embolism or DVT, serious wounds or fractures, uncontrolled intercurrent illness, HIV-positive subjects on antiretroviral therapy, receiving other investigational agents, or unwilling to use effective contraception are not eligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 years (6 years of accrual and 3 year follow-up after enrollment of last patient

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the treatment of non-rhabdomyosarcoma soft tissue sarcoma in both intermediate-risk and high-risk patients. The primary objectives include assessing the survival rates and pharmacokin

Who is the study for?

This trial is for individuals with non-rhabdomyosarcoma soft tissue sarcomas (NRSTS), including conditions like lipoma and liposarcoma. It aims to help those at intermediate or high risk of the disease progressing, by testing new combinations of drugs and therapies after initial diagnosis.

What is being tested?

The trial tests a regimen involving ifosfamide, doxorubicin, pazopanib, surgery, radiation therapy (including proton beam), and selinexor. For intermediate-risk patients, it focuses on survival rates using these treatments plus maintenance pazopanib. High-risk patients will have the dosage of selinexor optimized in combination with other drugs.

What are the potential side effects?

Potential side effects include nausea from chemotherapy drugs like ifosfamide and doxorubicin; high blood pressure or liver issues from pazopanib; fatigue or appetite changes from selinexor; skin reactions from radiation therapy; and surgical risks such as infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My sarcoma has a specific genetic change and is considered high-risk.

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My organs that will be exposed to radiation are functioning well.

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I was 30 years old or younger when my NRSTS was diagnosed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have cancer that started in or has spread to my brain.

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I do not have conditions that affect drug metabolism, serious wounds, or uncontrolled illnesses, and I am not on HIV treatment.

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My cancer type does not match the excluded list.

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I do not have uncontrolled high blood pressure, bleeding disorders, or prior treatment with specific medications.

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I am not pregnant, not breastfeeding, can prove I'm not pregnant, and will use birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 years (6 years of accrual and 3 year follow-up after enrollment of last patient

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 years (6 years of accrual and 3 year follow-up after enrollment of last patient

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 years (6 years of accrual and 3 year follow-up after enrollment of last patient for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free survival (EFS)

Maximum tolerated dose (MTD) and/or the recommended phase 2 dosage (RP2D)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Low-Risk Subset BExperimental Treatment2 Interventions

Participants with high-grade tumors that are \< 5 cm with positive margins. This means that the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed. These participants will have surgery followed by radiation therapy for about 5-6 weeks.

Group II: Low-Risk Subset AExperimental Treatment2 Interventions

Participants with low grade tumors of any size, or high-grade tumors \< 5 cm that have been (or are expected to be) completely removed by surgery. When the pathologist reviews the tumor specimen, the tissue around the tumor (margins) must be negative for cancer cells, meaning all of the cancer has been removed. These participants will have surgery to remove the tumor, followed by close observation. There will no further therapy after surgery, just monitoring for tumor recurrence and any side effects from surgery.

Group III: Intermediate-Risk Subset C (participants with high-grade tumors > 10 cm):Experimental Treatment5 Interventions

* After 3 cycles of induction chemotherapy, your doctor may decide to give an additional 4th cycle if he/she thinks it would be beneficial before surgery. * You will get consolidation therapy with additional chemotherapy and radiation therapy, followed by 6 months of maintenance therapy with pazopanib. The dose of radiation that you receive will be higher if your tumor cannot be completely removed at surgery (positive margins).

Group IV: Intermediate-Risk Subset B (participants with high-grade tumors between 5 and 10 cm in sizeExperimental Treatment5 Interventions

* If your tumor is completely removed at surgery \[meaning the tissue around the tumor (margins) is negative for tumor cells\] you will continue with consolidation chemotherapy with additional chemotherapy without radiation therapy, followed by 6 months of maintenance therapy with pazopanib. * If your tumor cannot be completely removed at surgery \[meaning the tissue around the tumor (margins) is positive for tumor cells\], you will get consolidation therapy with additional chemotherapy and radiation therapy, followed by 6 months of maintenance therapy with pazopanib.

Group V: Intermediate-Risk Subset A (participants with low grade tumors):Experimental Treatment5 Interventions

* If your tumor is completely removed at surgery \[meaning the tissue around the tumor (margins) is negative for tumor cells\], you will receive no further therapy and you will be closely observed for any signs of tumor recurrence. * If your tumor cannot be completely removed at surgery \[meaning the tissue around the tumor (margins) is positive for tumor cells\] and the tumor is low-grade, you will get consolidation therapy with additional chemotherapy and radiation therapy, followed by 6 months of maintenance therapy with pazopanib.

Group VI: High-Risk - 2 groupsExperimental Treatment6 Interventions

* If you have a low-grade tumor that has spread to other parts of the body AND the surgeon was able to completely remove all tumors from all parts of your body, you will have no further therapy after surgery. You will be closely followed to monitor you for any signs of tumor recurrence. * If you have a high-grade tumor OR a tumor that cannot be completely removed by surgery OR you have the CIC-DUX4 mutation, you will get consolidation chemotherapy and radiation therapy, followed by 6 months of maintenance therapy with pazopanib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

2012

Completed Phase 3

~8030

Pazopanib

2012

Completed Phase 4

~1700