Aflac ST1001 Prolonged Isotretinoin

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Neuroblastoma is a cancer of the nervous system and accounts for 15% of cancer related deaths in children. With the advancement of treatment therapies, the long term survival rate has progressed to approximately 50%. The therapy used for treatment, however, is very toxic and associated with serious long-term side effects. Treatment for neuroblastoma typically includes chemotherapy, surgery, stem cell transplantation, radiation therapy, and immunotherapy. At the end of this treatment, children with neuroblastoma commonly take the drug isotretinoin for 6 months. Isotretinoin maintains the response to previous treatments and helps turn the remaining cancer cells into normal nerve cells.

Most patients often respond to this treatment at first but are at a high-risk for the cancer coming back. The majority of the children who relapse after treatment or develop recurrent disease do so in the first two years following the completion of therapy and there are no current treatments to cure those who relapse. This study will explore whether or not extending the therapy with isotretinoin from 6 months to 24 months will help prevent the cancer from coming back without causing severe side effects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Children's Healthcare of Atlanta
• Treatments: Isotretinoin

Criteria

Inclusion Criteria:

• <=30 years of age

• histologic verification of neuroblastoma

• no active measurable disease on CT/MRI

• ultra high risk status by having mixed response, no response or stable disease following initial treatment or by having recurrent neuroblastoma

• Karnofsky >=50% for patients >16 years and Lansky >=50% for patients <=16 years

• patients must have completed high risk therapy

• organ function as defined in protocol

Exclusion Criteria:

• patients with active measurable disease

• patients who are pregnant or breast-feeding

• concomitant medications stopped as indicated in protocol

• patients with uncontrolled infection

• patients with history of depression or psychotic disorder requiring medication