An imaging study of 64Cu-SARTATE using positron emission tomography in paediatric patients with high-risk neuroblastoma.

Phase 1

Withdrawn

• Conditions: High-Risk Neuroblastoma; Cancer - Children's - Other

• Registration Number: ACTRN12617001259336
• Lead Sponsor: Clarity Pharmaceuticals LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-30
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Signed informed consent by parent or guardian.
2. Age at diagnosis less than or equal to 16 years.
3. Life expectancy greater than or equal to 12 weeks.
4. High-risk neuroblastoma with failure to respond to standard therapy, or development of progressive disease at any time, or patients with unresectable residual primary tumours if unsuitable for external beam radiotherapy.
5. At least one site of disease evaluable by 123I-MIBG SPECT.
6. Adequate recovery from acute toxic effects of any prior therapy.
7. At least one site of somatostatin receptor 2 positive malignancy.
8. Adequate renal function.
9. Karnofsky or Lansky performance status of greater than or equal to 50.

Exclusion Criteria

1. Patients with disease of any major organ system that would compromise their ability to tolerate therapy, as deemed by the principal investigator or treating sub-investigator.
2. Patients who require sedation during imaging procedures.
3. Patients must not receive chemotherapy, anti-cancer cytokine therapy or
other investigational agents within 2 weeks prior to Day 1.
4. Patients must not be undergoing treatment with long acting somatostatin analogues (administered within 28 days prior to Day 1), or short acting somatostatin analogues (administered within 24hrs prior to Day 1).
5. Patients who are pregnant or lactating are excluded. Patients of childbearing potential must practice an effective method of birth control.
6. Patients who are on hemodialysis.
7. Patients with a QTc interval less than or equal to 0.45 seconds as measured by screening ECG.
8. Patients with uncontrolled infections.
9. Any serious medical condition which the investigator feels may interfere with the
procedures or evaluations of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified