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Phase 1 Study of ABI-009 (nab-rapamycin) in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors as a Single Agent and in Combination with Temozolomide and Irinotecan

This phase I trial studies the side effects and best dose of nanoparticle albumin-bound rapamycin when given together with temozolomide and irinotecan hydrochloride in treating pediatric patients with solid tumors that have come back after a period of time during which the tumor could not be detected or has not responded to treatment. Nanoparticle albumin-bound rapamycin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nanoparticle albumin-bound rapamycin, temozolomide, and irinotecan hydrochloride may work better in treating pediatric patients with solid tumors.

Principal Investigator:
Josephine HaDuong, MD

Research Coordinator:
Kathryn Duvall
(714) 509-8646

Visit clinicaltrials.gov for more information about this trial.



  • Clinical Trial Info
  • IRB Number: 170768
  • Sponsor: Children's Oncology Group
  • Protocol Number: ADVL1514
  • NCT Number: NCT02975882
  • Research Type: Adolescents and Young Adults, Recurrent/Refractory Cancer, Solid Tumors
  • Phase: I
  • Status: Active - Open to Enrollment

Key Inclusion Criteria:

  • Age: 12 Months to 21 YearsPatients must have a body surface area (BSA) of >= 0.2 m^2 at the time of study enrollmentPatients with recurrent or refractory solid tumors, including CNS tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)Patients must have either measurable or evaluable diseaseStandard COG Phase 1 organ function requirements
    Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure:
  • Patients who have received prior single agent therapy with irinotecan, temozolomide, or an mTOR inhibitor, excluding ABI-009, are eligible
  • Patients who have received prior combination therapy with two of the three agents, excluding ABI-009, are eligible
  • Patients who have received prior therapy with all three agents in combination (i.e. irinotecan, temozolomide, and an mTOR inhibitor) are not eligible
  • Patients who have previously received irinotecan and temozolomide and had significant toxicity with these two drugs are not eligible

Key Exclusion Criteria:

  • Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
  • Patients who are currently receiving another investigational drug are not eligiblePatients who are currently receiving other anti-cancer agents are not eligiblePatients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
  • Patients must not have received enzyme-inducing anticonvulsants for at least 7 days prior to enrollmentPatients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others) are not eligible
  • Patients must not be receiving any strong CYP3A4 or P-glycoprotein (P-gp) inducers or inhibitors within 7 days prior to enrollment; moderate inducers or inhibitors of CYP3A4 and P-gp should also be avoided during ABI-009 treatment, if possiblePatients with interstitial lung disease and/or pneumonitis are not eligible
  • Patients who have had or are planning to have the following invasive procedures are not eligible:Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollmentSubcutaneous port placement or central line placement is not considered major surgery; external central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollmentCore biopsy within 7 days prior to enrollmentFine needle aspirate within 7 days prior to enrollment
  • NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapyPatients with current deep vein thrombosis or deep vein thrombosis within the past 6 months are not eligible

Long Live Childhood

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