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New treatment option for Adipocytic Neoplasm
Official title NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
ClinicalTrials.gov ID: NCT06239272
What this study is testing
What is Pazopanib?
Pazopanib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for adipocytic neoplasm.
Also referred to as VOTRIENT®.
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 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 30
You may be able to join if
- All Patients
- 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...
- Lansky performance status score ≥ 60 for patients ≤ 16 years of age. Karnofsky performance status score ≥ 60 for patients \>16 years of age. Note...
- Patients with CIC-DUX 4 rearranged sarcomas will be enrolled on the high-risk stratum only, regardless of presence of metastasis, size, or resection...
You likely can't join if
- Patients with known primary CNS sarcoma or CNS metastases are not eligible. Note: Brain imaging is not an eligibility requirement. Tumors with...
- Patients with the following histologic diagnosis are not eligible: intermediate locally aggressive tumors as defined by WHO, malignant rhabdoid...
- Bleeding diathesis: Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: Patients aged \> 17 years with excess of...
- Uncontrolled hypertension: Patients with uncontrolled hypertension (CTCAE v5 Grade ≥ 2) are ineligible. Hypertension must be well controlled on...
- Patients must have had no prior systemic therapy for the treatment of the NRSTS
- Patients must have had no prior anthracycline or ifosfamide chemotherapy
See the full eligibility criteria
Who can join
- All Patients
- 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...
- 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...
- 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...
- 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 \ 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.
- 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...
- 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...
- 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
- A normal serum creatinine based on age/gender as follows Age Maximum Serum Creatinine (mg/dL) Male Female 2 to \ 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. Anticoagulation Patients on low molecular weight...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- people 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baton Rouge, Louisiana, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Cincinnati, Ohio, United States
- Memphis, Tennessee, 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, up to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Chicago, Illinois, United States; Baton Rouge, Louisiana, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; Cincinnati, Ohio, United States and 1 more location(s). 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.