Solid Tumor Treatment With nab-Rapamycin, Temozolomide and Irinotecan – Phase I

ADVL1514: 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

Protocol Description

Through this Children’s Oncology Group (COG) study, researchers are evaluating the drug ABI-009 when used along with two other chemotherapy drugs fight recurrent tumors and tumors that will not respond to standard therapy. ABI-009, also called nanoparticle albumin-bound rapamycin or nab-rapamycin, has shown potential in laboratory tests. It will be given alone and in combination with temozolomide and irinotecan. As a Phase I cancer trial, this program evaluates the effects of the drug on tumors, as well as its side effects and how the body processes it. Researchers also evaluate the highest tolerable dosage level. This study is an initiative of COG’s Pediatric Early Phase Clinical Trial Network of which UPMC Children’s Hospital of Pittsburgh is a part.

Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling participants, ages 12 months to 21 years, who have cancer that has grown or come back after being treated with chemotherapy and/or radiation. Participants may remain in the study unless they develop serious side effects or their tumors worsen.
Males and Females: Ages 12 months to 21 years


Participants will be given intravenous (IV) infusions of ABI-009 twice during a 3-week cycle. Starting with the second cycle, ABI-009 will be combined with irinotecan and temozolomide, which will be taken orally on the first 5 days of the cycle. In addition to the IV infusions, study participants will have tests and procedures such as imaging and blood draws, as well as physical examinations at specific intervals.
Visits: At least 3 times per 3-week cycle for IV infusions and medical examinations
Duration: Open ended

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1514)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Andrew Bukowinski MD, MS