NCT01661400: ASCR

Anti-Angiogenic Therapy Post Transplant (ASCR) for Pediatric Solid Tumors

Completed Phase 1 Last updated 31 January 2024

What this trial tests

Phase 1 trial testing Metronomic Cyclophosphamide in Glioma in 14 participants. Completed in 27 December 2023.

Timeline

26 October 2012

Primary endpoint
27 December 2023

27 December 2023

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	26 October 2012
Primary completion	27 December 2023
Estimated completion	27 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Metronomic Cyclophosphamide — full drug profile →
• Thalidomide (THALIDOMIDE) — full drug profile →

Conditions studied

• Glioma — all drugs for Glioma →
• Neuroectodermal Tumors, Primitive — all drugs for Neuroectodermal Tumors, Primitive →
• Wilms Tumor — all drugs for Wilms Tumor →
• Rhabdomyosarcoma — all drugs for Rhabdomyosarcoma →

Sponsor

Washington University School of Medicine

Who can join

Adults 6 Months to 21, any sex, with Glioma or Neuroectodermal Tumors, Primitive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this research study is to determine whether taking either of two low dose drugs that would prevent new blood vessels from growing after stem cell transplant is feasible, and what the side effects of taking each of these drugs after autologous transplant might be. The reason the investigators are looking at these drugs is because one of the things that allows tumors to grow quickly is their ability to stimulate the growth of new blood vessels. By suppressing the growth of new blood vessels after stem cell transplant, the investigators hope to prevent the tumors from coming back or continuing to grow.

Publications & conference data

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

1. Trial watch: Chemotherapy with immunogenic cell death inducers.
   Vacchelli E, Senovilla L, Eggermont A, Fridman WH, et al · · 2013 · cited 83× · PMID 23687621 · DOI 10.4161/onci.23510
2. Pathogenesis and Current Treatment of Osteosarcoma: Perspectives for Future Therapies.
   Rathore R, Van Tine BA. · · 2021 · cited 81× · PMID 33809018 · DOI 10.3390/jcm10061182
3. Molecular stratifications, biomarker candidates and new therapeutic options in current medulloblastoma treatment approaches.
   Menyhárt O, Győrffy B. · · 2020 · cited 60× · PMID 31970590 · DOI 10.1007/s10555-020-09854-1
4. Medulloblastoma in children and adolescents: a systematic review of contemporary phase I and II clinical trials and biology update.
   Bautista F, Fioravantti V, de Rojas T, Carceller F, et al · · 2017 · cited 37× · PMID 28980418 · DOI 10.1002/cam4.1171
5. A systematic review of ongoing clinical trials in optic pathway gliomas.
   Hill CS, Devesa SC, Ince W, Borg A, et al · · 2020 · cited 19× · PMID 32556546 · DOI 10.1007/s00381-020-04724-1
6. The Tumor Microenvironment of Medulloblastoma: An Intricate Multicellular Network with Therapeutic Potential.
   van Bree NFHN, Wilhelm M. · · 2022 · cited 18× · PMID 36291792 · DOI 10.3390/cancers14205009
7. Immune profiling and immunotherapeutic targets in pancreatic cancer.
   Lenzo FL, Kato S, Pabla S, DePietro P, et al · · 2021 · cited 18× · PMID 33569421 · DOI 10.21037/atm-20-1076
8. Ikaros Proteins in Tumor: Current Perspectives and New Developments.
   Xia R, Cheng Y, Han X, Wei Y, et al · · 2021 · cited 12× · PMID 34950704 · DOI 10.3389/fmolb.2021.788440