A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor

Status Completed

Clinical Trial Summary

In spite of the overall success of treating Wilms tumor, certain patients still have poor clinical outcomes. The sub-optimal outcomes for patients with anaplastic histology and recurrent Wilms tumor warrant the identification of new therapeutic agents. The objective of this trial is to estimate the response rate to two cycles of intravenous topotecan in children with recurrent Wilms tumor of favorable histology that is refractory to standard curative therapy.

Clinical Trial Description

Topotecan administered intravenously over 30 minutes daily for 5 consecutive days for 2 consecutive weeks, with a two-day rest given in between the five-day treatment blocks. The topotecan dose started at 1.8 mg/m2/dosage and adjusted to attain a target systemic exposure of 80 plus or minus 10 ng-hr/ml.each cycle consists of 28 days and subsequent cycles can be administered upon hematological recovery. Patients with a CR, PR, or SD, can continue to receive up to a total of six cycles. Patients with PD are removed from the study.

Secondary Objectives include:

- To describe the anti-tumor activity of topotecan in children with recurrent Wilms tumor of anaplastic histology.

- To assess the relation between CYP3A4/5 genotype and the pharmacokinetics and pharmacodynamics of topotecan.

- To assess the relation between ABCG2 genotype and the pharmacokinetics and pharmacodynamics of topotecan. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Wilms Tumor

Clinical Trial Details

NCT number	NCT00187031
Study type	Interventional
Source	St. Jude Children's Research Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	November 2002
Completion date	October 2007

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01222780` - To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer	Phase 1
Completed	`NCT03655587` - Impact of an Orthotic Intervention in Children With Peripheral Neuropathy	N/A
Recruiting	`NCT05384821` - Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)	Phase 1/Phase 2
Active, not recruiting	`NCT03233204` - Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)	Phase 2
Completed	`NCT01661400` - Anti-Angiogenic Therapy Post Transplant (ASCR) for Pediatric Solid Tumors	Phase 1
Terminated	`NCT02536183` - A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors	Phase 1
Completed	`NCT01252901` - Registry for Patients With Wilms' Tumor Suppressor Gene 1 (WT1) Mutation Associated Diseases	N/A
Completed	`NCT02452554` - Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma	Phase 2
Recruiting	`NCT04851119` - Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT03220035` - Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial)	Phase 2
Active, not recruiting	`NCT03213678` - Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial)	Phase 2
Completed	`NCT04956198` - Drug Sensitivity and Mutation Profiling
Active, not recruiting	`NCT03698994` - Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)	Phase 2
Active, not recruiting	`NCT03213665` - Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)	Phase 2
Recruiting	`NCT04791228` - A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors	Phase 2
Active, not recruiting	`NCT04320888` - Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial	Phase 2
Completed	`NCT02714790` - Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia	N/A
Completed	`NCT01095926` - Pharmacokinetic Study of Doxorubicin in Children With Cancer	Phase 2
Active, not recruiting	`NCT02867592` - Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors	Phase 2
Withdrawn	`NCT01130623` - A Phase I Study of Pazopanib as a Single Agent for Children With Refractory Solid Tumors	Phase 1