Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases in Children and Young Adults With Refractory Sarcomas Wilms Tumor and Other Rare Tumors

Overview

This phase II trial studies how well cabozantinib-s-malate works in treating younger patients with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to therapy, or are newly diagnosed.

Description

The purpose of this study is to determine the objective response rate (complete response + partial response) of cabozantinib-s-malate (XL184) in children and young adults.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: sarcomas,Wilms tumor,rare tumors
  • Age: Between 2 Years - 30 Years
  • Gender: Male or Female

Inclusion Criteria
Upper age limit of == 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients == 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of M-Iodobenzylguanidine (MIBG); >= 3 months must have elapsed if prior craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total-body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given
Subjects should not have any clinically relevant ongoing complications from prior radiation therapy (i.e., radiation esophagitis or other inflammation of the viscera)
No evidence of active graft versus (vs.) host disease and >= 2 months must have elapsed since transplant
Not previously received XL184 or another MET/HGF inhibitor (tivantinib or crizotinib); there are no limits on number of prior therapeutic regimens; patients who have been treated with prior VEGF pathway, or RET inhibitors (except XL184) may be eligible
No clinically significant cardiac arrhythmias, stroke or myocardial infarction within 6 months prior to enrollment
Exclusion Criteria
Pregnant or breast-feeding women
Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment (14 days if pegfilgrastim)
Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Previous treatment with XL184 (cabozantinib) or another MET/HGF inhibitor (tivantinib, crizotinib)
Patients who are currently receiving another investigational drug are not eligible
Patients who are currently receiving other anti-cancer agents are not eligible
Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial
Patients must not be receiving any of the following potent CYP3A4 inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John's wort
Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin, and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) are prohibited
Patients must not have received enzyme-inducing anticonvulsants within 14 days prior to enrollment
Patients who are receiving drugs that prolong QTc are not eligible
Patients who are unable to swallow intact tablets are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Patients with active bleeding are not eligible; specifically, no clinically significant gastrointestinal (GI) bleeding, GI perforation, intra-abdominal abscess or fistula for 6 months prior to enrollment, no hemoptysis or other signs of pulmonary hemorrhage for 3 months prior to enrollment; patients with evidence of an acute intracranial or intratumoral hemorrhage on CT or MRI are not eligible (patients with evidence of resolving hemorrhage will be eligible); in patients with CNS tumors, an MRI with ECHO gradient sequences would be required to exclude presence of petechial hemorrhages
Patients who have had or are planning to have the following invasive procedures are not eligible:
Major surgical procedure, laparoscopic procedure, or open biopsy within 28 days prior to enrollment
Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines (e.g., Hickman or Broviac catheter, peripherally inserted central catheter [PICC]) and at least 7 days prior to enrollment for a subcutaneous port
Core biopsy within 7 days prior to enrollment
Fine needle aspirate within 7 days prior to enrollment
Surgical or other wounds must be adequately healed prior to enrollment
Patients who have had significant traumatic injury within 28 days prior to enrollment are not eligible
Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of the study drug are not eligible


Additional Information:
Participants will not be paid for their participation.

Updated on 30 Nov 2022 . Study ID: TX7854

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