A Phase 1/2 Study of Valproate in Combination with Interferon alpha in Relapsed, Recurrent or Progressive Neuroblastoma

Phase 1

• Conditions: Relapsed, Recurrent or Progressive Neuroblastoma; Cancer - Children's - Other

• Registration Number: ACTRN12610000842066
• Lead Sponsor: Australian and New Zealand Children's Haematology and Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-06
• Study Completion: 2016-11-08
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified