Ignite Creation Date:
2024-05-06 @ 12:00 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01467986
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2011-10-27
Brief Title:
Multimodal Molecular Targeted Therapy to Treat Relapsed or Refractory High-risk Neuroblastoma
Sponsor:
University of Regensburg
Organization:
University of Regensburg
Study Overview
Official Title:
Prospective Open Label Randomized Phase II Trial to Assess a Multimodal Molecular Targeted Therapy in Children Adolescent and Young Adults With Relapsed or Refractory High-risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIST-rNB-2011
Brief Summary:
Children adolescents and young adults with high risk relapsed or treatment refractory neuroblastoma rNB represent a group of patients with dismal prognosis for whom a recommended standard salvage therapy is currently not available
The multimodal metronomic approach combining molecular targeted drugs rapamycin and dasatinib with conventional chemotherapy irinotecan and temozolomide will be investigated in a randomized fashion as new treatment strategy for patients with rNB The intention is to assess the therapeutic benefit of molecular targeted drugs for the treatment of rNB
The combination of irinotecan and temozolomide showed activity in the treatment of several solid organ tumors brain tumors and neuroblastoma In one study rNB patients received a median of 5 courses of 5 days irinotecan and temozolomide every 3 to 4 weeks with a cumulative dose of 35 lower than in the RIST design 33 had disease regression with 8 CR or PR A phase II study in rNB also using irinotecan and temozolomide with a substantially lower intensity showed a response rate of 15
The combination of a mTOR inhibitor with a multi-kinase inhibitor demonstrated in preclinical studies a synergistic effect on cell cycle arrest apoptosis and sensitization for radio- and chemotherapy It is assumed that this combination of molecular targeted drugs with a tolerable conventional chemotherapy consisting of irinotecan and temozolomide can substantially improve the outcome of this patient population A group of 20 rNB patients treated with the RIST therapy approach in a compassionate use setting showed an overall survival of 55 at a median of 80 weeks with a tolerable adverse event profile
The multimodal metronomic approach combining molecular targeted drugs rapamycin and dasatinib with conventional chemotherapy irinotecan and temozolomide will be investigated in a randomized fashion as new treatment strategy for patients with rNB The intention is to assess the therapeutic benefit of molecular targeted drugs for the treatment of rNB
The combination of irinotecan and temozolomide showed activity in the treatment of several solid organ tumors brain tumors and neuroblastoma In one study rNB patients received a median of 5 courses of 5 days irinotecan and temozolomide every 3 to 4 weeks with a cumulative dose of 35 lower than in the RIST design 33 had disease regression with 8 CR or PR A phase II study in rNB also using irinotecan and temozolomide with a substantially lower intensity showed a response rate of 15
The combination of a mTOR inhibitor with a multi-kinase inhibitor demonstrated in preclinical studies a synergistic effect on cell cycle arrest apoptosis and sensitization for radio- and chemotherapy It is assumed that this combination of molecular targeted drugs with a tolerable conventional chemotherapy consisting of irinotecan and temozolomide can substantially improve the outcome of this patient population A group of 20 rNB patients treated with the RIST therapy approach in a compassionate use setting showed an overall survival of 55 at a median of 80 weeks with a tolerable adverse event profile
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None