None listed
Conditions
Brief summary
This study looks at the effectiveness of valproate in combination with interferon alpha in treating relapsed, recurrent or progressive neuroblastoma in children. Who is it for? You can join this study if you are 21 years or younger with relapsed or refractory (stubborn and resistant to treatment) neuroblastoma and you have no other effective treatment options available. Participants will receive treatment with a specific combination of valproic acid and interferon. Valproic acid is an anticonvulsant that has been shown to have an anti-cancer effect. New data has shown that the combination of valproic acid and interferon has an anit-neuroblastoma effect. The study aims to assess the effectiveness of this treatment, and monitor toxicity and side effects.
Interventions
Course 1: Interferon: 3 MU/m2 subcutaneous (SC) given 3 times per week. Valproate: commence at 10 mg/kg/day, increase weekly until trough level reaches 525-700 micromoles/L.
Courses 2-12: Interferon: 3 MU/m2 SC given 3 times per week. Valproate: dose to maintain trough at 525-700 micromoles/L
Mode of administration: Valproate - oral, Interferon - subcutaneous injection
Treatment duration is 12 courses. Due to the time required for dose escalation to reach desired concentration range, Course
Course 1: Interferon: 3 MU/m2 subcutaneous (SC) given 3 times per week. Valproate: commence at 10 mg/kg/day, increase weekly until trough level reaches 525-700 micromoles/L. Courses 2-12: Interferon: 3 MU/m2 SC given 3 times per week. Valproate: dose to maintain trough at 525-700 micromoles/L Mode of administration: Valproate - oral, Interferon - subcutaneous injection Treatment duration is 12 courses. Due to the time required for dose escalation to reach desired concentration range, Course 1 may be significantly longer than 28 days. Interferon therapy will continue throughout Course 1, whatever its length. All subsequent treatment courses will be 28 days in duration.
Sponsors
Australian and New Zealand Children's Haematology and Oncology Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 21 Years
Healthy volunteers
No
Inclusion criteria
Target tumour is neuroblastoma. Patient must have one of the following: - recurrent disease following aggressive multidrug frontline chemotherapy and autologous transplantation - resistent/refractory disease during aggressive multidrug frontline chemotherapy Patients must have measurable disease Patients must have a performance level of 0, 1, or 2 using Karnofsky scale or Lansky scale Patients must have a life expectancy of greater than or equatl to 8 weeks Patients must have fully recovered from the actue toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering the study Patients must have adequate organ function
Exclusion criteria
Patients with recurrent or progressive benign lesions without viable malignant neuroblastoma Patients do not meet concomitant medication restrictions For female patients, pregnancy and breast feeding Myeloplastic syndrome Uncontrolled infection
Outcome results
None listed