Is NCT06239272 recruiting in St Louis, MO?

Yes, NCT06239272 is currently recruiting participants at its St Louis, MO location. This soft tissue sarcoma clinical trial is actively enrolling qualified participants.

How do I join the soft tissue sarcoma clinical trial in St Louis?

To join this clinical trial in St Louis, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this St Louis clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Soft Tissue Sarcoma Clinical Trial in St Louis, MO

About This Soft Tissue Sarcoma Study in St Louis

The study participant has been diagnosed with non-rhabdomyosarcoma (NRSTS). Primary Objectives Intermediate-Risk * To estimate the 3-year event-free survival for intermediate-risk patients treated with ifosfamide, doxorubicin, pazopanib, surgery, and maintenance pazopanib, with or without RT. * To characterize the pharmacokinetics of pazopanib and doxorubicin in combination with ifosfamide in intermediate-risk participants, to assess potential covariates to explain the inter- and intra-indivi

Sponsor: St. Jude Children's Research Hospital

Who Can Participate

Inclusion Criteria

Patients must be 1-30 years at the time of the biopsy that established the diagnosis of NRSTS.

Surgical Resection: Patients who had an upfront resection prior to enrollment will be eligible if they are able to begin therapy within 28 days of resection assuming other eligibility criteria are met. Delayed resection is preferred for all patients with intermediate and high-risk disease.

Lansky performance status score ≥ 60 for patients ≤ 16 years of age. Karnofsky performance status score ≥ 60 for patients \>16 years of age. Note patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. Diagnosis • 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 has low-risk disease if the patient has a:

Low-grade tumor of any size where R0 or R1 surgical margins are anticipated or achieved.

High-grade tumors that are \< 5 cm where R0 or R1 resection margins are anticipated or achieved. Patient must have adequate organ function in the organs that will be within the radiotherapy field. Adequate renal function defined as:

Creatinine clearance or radioisotope GFR \> 70 mL/min/1.73 m2, or

A normal serum creatinine based on age/gender as follows Age Maximum Serum Creatinine (mg/dL) Male Female 2 to \< 6 years 0.8 0.8 6 to \< 10 years 1 1 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4 \> 16 years 1.5 1.4 Adequate liver function defined as:

Total bilirubin \< 1.5 x upper limit of normal (ULN) for age

SGOT (AST) or SGPT (ALT) \< 2.5 x ULN for age Adequate cardiac function defined as:

Ejection fraction of \> 55% by echocardiogram or cardiac MRI

QTc \< 480 msec Adequate pulmonary function defined as:

No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading \> 94% on room air if there is clinical indication for determination. Inclusion Criteria - Intermediate and High Risk Participants Patient has intermediate-risk if the patient has a:

Low-grade non-metastatic initially unresectable disease at study enrollment where delayed resection is planned.

High-grade \< 5 cm non-metastatic initially unresectable disease at study enrollment where delayed resection is planned. Of note, patients enrolled on the low-risk arm who were unable to achieve gross total resection where delayed re-resection is planned are eligible for this arm.

High-grade tumor \> 5 cm that is potentially resectable. Patient high-risk if the patient has:

Metastatic disease at presentation

Unresectable disease at study enrollment where delayed resection is not anticipated. Of note, patients enrolled on the low-risk arm who were unable to achieve gross total resection where delayed re-resection is not-planned are eligible for this arm.

CIC-DUX4 rearranged sarcoma Organ Function Adequate bone marrow function defined as:

Absolute neutrophil count \> 1000/µL

Platelet count \> 100,000/µL

Hemoglobin \> 8 g/dL for patients \< 16 years of age

Hemoglobin \> 9 g/dL for patients \> 16 years of age Note: No transfusions are permitted 7 days prior to laboratory studies to determine eligibility. Adequate renal function defined as:

Creatinine clearance or radioisotope GFR \> 70 mL/min/1.73 m2, or

Total bilirubin \< 1.5 x upper limit of normal (ULN) for age

SGOT (AST) or SGPT (ALT) \< 2.5 x ULN for age Adequate cardiac function defined as:

Ejection fraction of \> 55% by echocardiogram or cardiac MRI

QTc \< 480 msec Adequate pulmonary function defined as:

No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading \> 94% on room air if there is clinical indication for determination. Anticoagulation Patients on low molecular weight heparin, warfarin (with a stable INR), or direct oral anticoagulants (DOAC) who have been on a stable dose of are eligible. Patients being treated for a pulmonary embolism or deep venous thrombosis (DVT) must have been treated for a minimum of 6 weeks prior to starting therapy treatment. Life Expectancy Patient must have a life expectancy of at least 3 months with appropriate therapy.

Exclusion Criteria

Patients with known primary CNS sarcoma or CNS metastases are not eligible. Note: Brain imaging is not an eligibility requirement. Tumors with intracranial extension will be allowed.

Patients with the following histologic diagnosis are not eligible: intermediate locally aggressive tumors as defined by WHO, malignant rhabdoid tumor, alveolar soft part sarcoma, infantile fibrosarcoma, unresectable/metastatic dermatofibrosarcoma protuberans, inflammatory myofibroblastic tumor, desmoid fibromatosis, rhabdomyosarcoma, desmoplastic small round cell tumor, BCOR-CCNB3 fusion positive sarcoma.

Bleeding diathesis: Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: Patients aged \> 17 years with excess of 2.5 mL of hemoptysis are not eligible).

Uncontrolled hypertension: Patients with uncontrolled hypertension (CTCAE v5 Grade ≥ 2) are ineligible. Hypertension must be well controlled on stable doses of medication for at least two weeks. Prior Therapy

Patients must have had no prior systemic therapy for the treatment of the NRSTS

Patients must have had no prior anthracycline or ifosfamide chemotherapy

Patients must have had no prior use of pazopanib or similar multi-targeted TKI. Patients must have had no prior radiotherapy to tumor-involved sites. Note: Patients previously treated for a non-NRSTS cancer are eligible provided they meet the prior therapy requirements. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded.

CYP3A4 Substrates WITH Narrow Therapeutic Indices: Patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible. Note: the use of fentanyl is permitted.

CYP3A4 Inhibitors: Patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin, many NNRTIs, diltiazem, verapamil, and grapefruit juice are not eligible.

CYP3A4 Inducers: Patients chronically receiving drugs that are known potent CYP3A4 inducers within 14 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort are not eligible (with the exception of glucocorticoids).

Certain medications that are associated with a risk for QTc prolongation and/or Torsade's de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible.

Subjects with any condition that may impair the ability to absorb oral medications/investigational product including:

prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel

active peptic ulcer disease

malabsorption syndrome 3.4.12 Thyroid Replacement Therapy: Patients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 4 weeks prior to study enrollment. 3.4.13 Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:

active peptic ulcer disease

known intraluminal metastatic lesions

inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation

history of abdominal fistula, gastrointestinal perforation or intra- abdominal abscess within 28 days prior to beginning study treatment. 3.4.14 Pulmonary embolism or DVT. Patients must not have experienced:

An untreated pulmonary embolism or DVT in last 6 months or

treated pulmonary embolism or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks

arterial thrombosis in last 12 months History of serious or non-healing wound, ulcer, or bone fracture. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pazopanib. In addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive therapy. Patients who are receiving any other investigational agent(s). Pregnancy and Breast Feeding

Pregnancy and Breast Feeding Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies.

Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment.

Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.

Unwillingness to use an effective contraceptive method for the duration of their study participation and for at least 1 month after treatment is completed if sexually active with reproductive potential.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in St Louis?

Yes, this clinical trial (NCT06239272) has an active research site in St Louis, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Soft Tissue Sarcoma Treatment Options in St Louis, MO

If you're searching for soft tissue sarcoma treatment options in St Louis, MO, this clinical trial (NCT06239272) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our St Louis research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced soft tissue sarcoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all soft tissue sarcoma clinical trials near you to find additional studies recruiting in your area.

Soft Tissue Sarcoma Clinical Trial in St Louis, MO

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