Relapsed/refractory solid tumours Cancer Neoplasm of uncertain or unknown behaviour of other and unspecified sites
Conditions
Interventions
Figitumumab given on day 1 of a three weekly cycle as a 2.5 hour intravenous (IV) infusion. Starting dose 6 mg/kg with escalation cohorts that include 10 mg/kg, 20 mg/kg and 30 mg/kg.
In cycle one on
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged greater than 1 years and less than 12 years, either sex 2. Histological confirmation of solid extra cranial malignancy at original diagnosis 3. Phase 2 cohort only: measureable or clinically evaluable disease 4. Current disase status must be one for which no available curative therapy 5. Performance status Lansky greater than 50% or Eastern Cooperative Oncology Group (ECOG) less than 2 6. Adequate recovery from major surgery prior to treatment 7. No mitral valve regurgitation greater than trivial as determined by Doppler echocardiogram. Shortening of fraction less than or equal to 29%. Electrocardiogram (ECG) should be normal. 8. Must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy. Two weeks from previous chemotherapy, four weeks from previous radiotherapy and six weeks from previous nitrosureas or myeloablative chemotherapy. 9. Adequate bone marrow function 10. Adequate renal function 11. Adequate liver function 12. Males or females of reproductive potential may not participate unless they agree to use an effective contraceptive method 13. All patients and/or their parents or legal guardians must sign a written informed consent 14. Patients and/or their parents and/or legal guardians must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion criteria
Exclusion criteria: 1. Concurrent treatment with any anti-tumour agents 2. Prior anti-IGF-1R therapy 3. Patients with symptomatic brain metastases 4. Significant active cardiac disease 5. Active infection 6. Poorly controlled Insulin-dependent diabetes mellitus 7. History of allergic reaction to immunoglobulin G (IgG) 8. Other severe acute or chronic medical or psychiatric condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, measured by assessment of adverse events and laboratory abnormalities using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 assessing grade timing, seriousness and relatedness. Outcome will be measured after cycle 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic blood sampling looking at plasma figitumumab concentrations, anti-drug antibodies, serum IGF-1/2, insulin-like growth factor binding protein 3 (IGFCP-3), insulin and growth hormone levels, measured Cycle 1 day 1, 2 and 8 and then prior to cycle 4. Antidrug antibodies measured cycle 1 day 1 and end of treatment. 2. Response to treatment measured by Response Evaluation Criteria In Solid Tumours (RECIST) criteria or by nuclear imaging or histology, measured every 2 cycles | — |
Countries
France, United Kingdom
Outcome results
None listed