Clinical Trials / START Pediatrics

Clinical Trials

The Pediatric Hematology and Oncology Unit has a dedicated unit for the development of Phase I-IV clinical trials in pediatric hematology and oncology (START Pediatrics).

START Pediatrics is the Clinical Trials Unit in Pediatric Oncology and Hematology integrated into START Madrid–CIOCC and the Pediatric Hematology and Oncology Department at HM Montepríncipe. It is directed by Dr. Marta Osuna and forms part of the international START network, dedicated to the development of Phase I and Phase II–IV clinical trials.

The Unit provides access to innovative therapies within regulated protocols and under strict ethical supervision, integrating specialized clinical care and advanced research.

Phase I, II, III and IV clinical trials

• Development of early-phase trials (Phase I and II) and late-phase trials (Phase III–IV).
• Methodology and quality standards shared with START Madrid–CIOCC.
• Specialized medical supervision and continuous patient follow-up.

Clinical infrastructure

START Pediatrics has specific infrastructure for the development of clinical trials:

• Pharmacy dedicated to investigational medicinal products, with clean room and biological safety cabinet.
• Consultation rooms and treatment chairs exclusively for patients enrolled in clinical trials.
• In-house laboratory with same-day sample processing and monitored storage systems.
• Procedure room for biopsies, bone marrow aspirates and lumbar punctures.
• Isolation rooms with continuous monitoring (“Onco-ICU”).
• Access to tertiary-level neonatal, pediatric and adult ICU services.

Non-clinical infrastructure and regulatory support

• Paperless digital environment with electronic documentation and full traceability.
• Remote monitoring and compliance with international standards (GCP).
• Data Management and Regulatory Affairs teams shared with START Madrid–CIOCC.
• Experience with international clinical study management platforms.

Patient population and access

The Unit treats patients from birth to 18 years of age, as well as adolescents and young adults with tumors of pediatric origin. Patients with private insurance, civil servant mutual insurance schemes, international patients and self-funded cases are accepted.

Patients enrolled in clinical trials receive the study treatment free of charge, even in the absence of private insurance.

Comprehensive care

START Pediatrics forms part of a multidisciplinary care model that integrates all pediatric and adult specialties, including radiotherapy, nuclear medicine, autologous transplantation, targeted therapies, immunotherapy and CAR-T. The Unit also offers psychological support, social work, physiotherapy, volunteering and educational programs for hospitalized patients.

Infrastructure

Discover our facilities:

Technical information

You may consult the complete technical dossier in English, with detailed information on the structure and capabilities of the program:

Download technical dossier in English (PDF)

Additional information

You may find further information at the following link: The START Center for Cancer Research

Clinical trials currently open for recruitment

Phase I/II

• LuPARPed. Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for recurrent or relapsed solid tumours expressing somatostatin receptor (SSTR) (LuPARPed). NCT06607692.
  Eligible patients:
  • ≤ 18 years of age at diagnosis, with no age limit at the time of inclusion
  • Relapsed/refractory tumors expressing somatostatin receptors: HGG, meningioma, medulloblastoma, neuroblastoma, lymphomas, paraganglioma, pheochromocytoma, osteosarcoma…
  • Treatment with Lutathera + olaparib
  For more information: clinicaltrials.gov/study/NCT06607692
  Dr. Marta Osuna (Principal Investigator) – marta.osuna@startmadrid.com

Phase II

• TPX-0005-07. A study of repotrectinib in pediatric and young adult subjects harboring ALK, ROS1 or NTRK1-3 alterations. NCT04094610.
  • Children, adolescents and young adults up to 25 years of age
  • Tumors with:
    • NTRK fusion treated with one or two prior lines of NTRK inhibitors
    • ROS1 fusion in first or subsequent lines of treatment
  • Treatment with repotrectinib
  For more information: clinicaltrials.gov/study/NCT04094610
  Dr. Marta Osuna (Principal Investigator) – marta.osuna@startmadrid.com

Phase IV

• UMBRELLA PROTOCOL SIOP-RTSG 2016. EudraCT 2016-004180-39 (since 2019).
• Eligible patients:
  • Any age (renal carcinoma only < 18 years)
  • Newly diagnosed renal tumors: Wilms tumor, clear cell sarcoma, renal carcinoma, rhabdoid tumor, mesoblastic nephroma, other renal tumors

Not recruiting

Phase I

• D3820C00016. Naloxegol in pediatric patients receiving opioid treatment. NCT02099591.
  Duration: 2014–2021.

Phase II

• XM22-08. Lipegfilgrastim vs filgrastim in tumors of the Ewing family or rhabdomyosarcoma. EudraCT 2015-000087-34.
  Duration: 2015–2019.
• A6301094. Dalteparin (Fragmin®) in pediatric venous thromboembolism. NCT00952380.
  Duration: 2016–2018.
• I3Y-MC-JPEH (NCT06413706) Phase 1b/2 clinical trial evaluating abemaciclib (Verzenios) in combination with temozolomide for children and young adults (≤20 years) with newly diagnosed high-grade glioma after radiotherapy. Duration: 2024-2025.

Phase III

• PHITT. Pediatric liver tumors (hepatoblastoma, hepatocarcinoma). EudraCT 2016-002828-85.
  Duration: 2018–2024.
• 20120215. Blinatumomab vs standard chemotherapy in high-risk ALL in first relapse. NCT02393859.
  Duration: 2016–2022.
• LINES. Low- and intermediate-risk neuroblastoma. NCT01728155.
  Duration: 2016–2022.
• LINESG2. Resectable localized neuroblastoma. SIOPEN.
  Duration: 2004–2012.
• SIOPEL 3. Pediatric liver tumors.
  Duration: 1998–2006.
• SIOPEL 6. Sodium thiosulfate to reduce cisplatin-induced ototoxicity. NCT00652132.
  Duration: 2007–2017.
• Inter-B-NHL ritux 2010. Rituximab in high-risk pediatric B-cell non-Hodgkin lymphoma. EudraCT 2010-019224-31. NCT01516580.
  Duration: 2012–2021.
• B0661037. Anticoagulation in pediatric venous thromboembolism. NCT02464969.
  Duration: 2016–2024.

Phase IV and academic studies:

• HR-NBL-1. High-risk neuroblastoma. SIOPEN. Duration: 2002–2017.
• PGA111081. Nelarabine in relapsed/refractory T-cell ALL. NCT00866671.
  Duration: 2008–2014.
• SIOP PNET5. Standard-risk medulloblastoma, low- and average-risk biological profiles.
  Duration: 2016–2022.
• R-0014/18. Asparaginase monitoring in ALL (SEHOP-PETHEMA 2013).
  Duration: 2018–2019.
• LCH-IV. International protocol for Langerhans cell histiocytosis. EudraCT 2011-001699-20.
  Duration: until 2025
• EpSSG NRSTS 2005. EudraCT 2005-001139-31.