Clinical Trials / Research Studies

Clinical Trials / Research Studies

Who can participate?

Diagnosis of 1 of the Following:
Histologically confirmed relapsed or refractory solid tumors at original diagnosis including CNS tumors* (Part 1 and Part 2a)

• Neurologic deficits in patients with CNS tumors must have been relatively stable for ≥1 week
• Histologically confirmed soft tissue sarcoma, desmoplastic small round cell tumor, or extraosseous Ewing sarcoma at original diagnosis including the following (Part 2b):
• Tumor in the head, neck, or extremity or fixed within the abdomen or pelvis that it is not sensitive to motion artifact
• No isolated pulmonary metastases
• Slides or tissue blocks from either initial diagnosis or relapse must be available for central review
• NOTE: Histologic confirmation not required for intrinsic brain stem cell tumor, optic pathway gliomas, pineal tumors and elevations of cerebrospinal fluid, and serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin.
• Disease with no known curative therapy or no therapy proven to prolong survival with acceptable quality of life
• Measurable or evaluable disease (Part 1 and Part 2a)
• Measurable tumor that is ≥2 cm in its longest diameter (Part 2b)
• Patients must be:
• > 2 years of age and ≤21 years of age (Part 1 and Part 2a)
• > 2 years of age and ≤25 years of age (Part 2b)
• Body surface area ≥0.48 m2 (Part 1 and Part 2b)
• For patients with CNS tumors or CNS metastasis, there must be no evidence of new CNS hemorrhage of more than punctate size and/or > 3 foci of punctate hemorrhage on baseline MRI for primary CNS tumors ≥14 days prior to study entry