NCT02446431: Metronomic

Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence: A Multi-Institutional Study

Recruiting now EARLY_PHASE1 Last updated 13 May 2015

What this trial tests

EARLY_PHASE1 trial testing Bevacizumab in Solid Tumor in 20 participants. Currently enrolling.

Timeline

1 July 2014

Primary endpoint
1 July 2024

1 July 2029

Quick facts

Lead sponsor	Miller Children's & Women's Hospital Long Beach
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	20
Start date	1 July 2014
Primary completion	1 July 2024
Estimated completion	1 July 2029
Sites	2 locations across United States

Drugs / interventions tested

• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Valproic Acid (valproic acid) — full drug profile →
• Temsirolimus (temsirolimus) — full drug profile →

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →

Sponsor

Miller Children's & Women's Hospital Long Beach

Who can join

Adults 12 Months to 31, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 5 year Event Free Survival
  Time frame: Up to five years off therapy
  Imaging studies, laboratory studies, bone marrow exam
• Number of Participants with Adverse Events as a Measure of Safety and Tolerability
  Time frame: Up to five years off therapy
  Imaging studies, laboratory studies, bone marrow exam

Sponsor's own description

Most pediatric patients with solid tumors respond to initial high-dose, intensive therapy and complete treatment in remission. High-risk patients however, frequently have recurrent disease which is then treated with ad hoc regimens or early phase therapies with little benefit to the patient. Metronomic therapy (MC), defined as lower dose continuous drug exposure, has been successfully tested in pediatric leukemias with excellent results in terms of improved outcome, toxicity profiles, and cost. MC has been applied to solid tumors with little success, but has been implemented usually in the relapsed setting at a time of high tumor burden and disease resistance.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut microbiota influence immunotherapy responses: mechanisms and therapeutic strategies.
   Lu Y, Yuan X, Wang M, He Z, et al · · 2022 · cited 360× · PMID 35488243 · DOI 10.1186/s13045-022-01273-9
2. Metronomic Chemotherapy.
   Cazzaniga ME, Cordani N, Capici S, Cogliati V, et al · · 2021 · cited 63× · PMID 34066606 · DOI 10.3390/cancers13092236
3. The role of metabolic ecosystem in cancer progression - metabolic plasticity and mTOR hyperactivity in tumor tissues.
   Sebestyén A, Dankó T, Sztankovics D, Moldvai D, et al · · 2021 · cited 35× · PMID 35029792 · DOI 10.1007/s10555-021-10006-2
4. Gut microbiota shapes cancer immunotherapy responses.
   Lei W, Zhou K, Lei Y, Li Q, et al · · 2025 · cited 33× · PMID 40715107 · DOI 10.1038/s41522-025-00786-8
5. Colorectal Cancer Immunotherapy: State of the Art and Future Directions.
   Cornista AM, Giolito MV, Baker K, Hazime H, et al · · 2023 · cited 30× · PMID 38098742 · DOI 10.1016/j.gastha.2023.09.007
6. The therapeutic potential of targeting the PI3K pathway in pediatric brain tumors.
   Rogers HA, Estranero J, Gudka K, Grundy RG. · · 2017 · cited 13× · PMID 27926496 · DOI 10.18632/oncotarget.13781
7. Targeting protein synthesis pathways in MYC-amplified medulloblastoma.
   Kumar D, Kanchan R, Chaturvedi NK. · · 2025 · cited 5× · PMID 39779613 · DOI 10.1007/s12672-025-01761-7
8. mTOR hyperactivity and <i>RICTOR</i> amplification as targets for personalized treatments in malignancies.
   Sztankovics D, Moldvai D, Petővári G, Dankó T, et al · · 2024 · cited 4× · PMID 38515456 · DOI 10.3389/pore.2024.1611643