Actively Recruiting
ANGIO-A: Safety and Tolerability of Oral Cyclophosphamide and Sorafenib With Intravenous Bevacizumab and Atezolizumab in Pediatric Solid Tumor Patients
Led by St. Jude Children's Research Hospital · Updated on 2026-05-19
64
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining four treatments—intravenous atezolizumab, bevacizumab, daily oral cyclophosphamide, and pharmacokinetic-guided sorafenib—in children, adolescents, and young adults with relapsed or refractory solid tumors. The study is divided into two parts: Part 1 focuses on safety and dosing in various solid tumors, while Part 2 assesses the response rate in fibrolamellar carcinoma (FLC) and other rare tumors. This phase I/II trial also explores immune responses and pharmacokinetics related to these drug combinations. Participants receive oral cyclophosphamide daily for 21 days, oral sorafenib twice daily for 21 days with doses adjusted based on blood levels, and intravenous atezolizumab and bevacizumab every three weeks. Part 1 involves determining the maximum tolerated dose and pharmacokinetic targets after one or two treatment cycles. Part 2 uses the recommended doses from Part 1 to further study treatment responses in specific tumor types, with tumor biopsies before treatment and after two cycles to evaluate immune cell changes. Throughout the study, participants undergo regular assessments including tumor biopsies, blood tests, imaging, and monitoring of immune and pharmacokinetic markers. Researchers measure treatment safety, tumor response rates, progression-free survival, and overall survival. Quality of life and family impact are also evaluated through interviews and questionnaires. The total duration varies but includes at least two treatment cycles of 21 days each, with ongoing monitoring for treatment effects and side effects.
CONDITIONS
Brief Title
Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be younger than 30 years at enrollment.
- Willing to enroll in the St. Jude Molecular Analysis of Solid Tumors (MAST) study.
- Part 1: Have relapsed or refractory solid tumors accessible by biopsy with no standard therapy available.
- Part 2: Have biopsy-accessible relapsed or refractory hepatocellular carcinoma, fibrolamellar carcinoma, desmoplastic small round cell tumor, or non-CNS malignant rhabdoid tumor.
- Karnofsky performance status over 50 for patients older than 16 years; Lansky performance status over 50 for patients younger than 16 years.
- Tumors must be unresectable with measurable or evaluable disease accessible by biopsy.
- Adequate organ function including kidney, liver, heart, blood counts, and clotting as specified.
- Females of childbearing potential and males able to father a child must agree to use birth control during the study and for 5 months after last dose.
- Fully recovered from prior chemotherapy, immunotherapy, surgery, or radiotherapy within specified timeframes.
- No history of severe cardiac disease or uncontrolled hypertension.
- Negative pregnancy test for post-menarchal females.
- Life expectancy of at least 8 weeks.
You will not qualify if you...
- Pregnant or breastfeeding individuals.
- Currently receiving other investigational drugs.
- Unable or unwilling to comply with safety monitoring requirements.
- Tumor not safely accessible for biopsy.
- Unable or unwilling to provide informed consent.
- Presence of chronic non-healing wounds, ulcers, bone fractures, or major surgery within 28 days before treatment.
- Recent minor surgeries allowed if fully healed and at least 7 days elapsed.
- Deep vein or arterial thrombosis within 3 months prior to study entry.
- Known thrombophilic conditions such as protein deficiencies or clotting disorders.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks (2 cycles of 21 days each)
Participants receive two courses of oral cyclophosphamide and sorafenib, with intravenous bevacizumab and atezolizumab. Treatment cycles are 21 days each, and tumor biopsies are done before starting treatment and after two cycles to evaluate changes in tumor and immune cells.
Visits every 3 weeks for infusions and daily oral medication during each cycle
Trial Site Locations
Total: 2 locations
1
Methodist Le Bonheur Healthcare
Germantown, Tennessee, United States, 38138
Withdrawn
2
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
J
Jessica Gartrell, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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