Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 3:16 AM
Study NCT ID:
NCT00946335
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2009-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABT-888 and Temozolomide in Treating Young Patients With Recurrent or Refractory CNS Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase I Study of ABT-888, an Oral Inhibitor of Poly (ADP-Ribose) Polymerase and Temozolomide in Children With Recurrent/Refractory CNS Tumors
Status:
COMPLETED
Status Verified Date:
2014-06
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:
None
Brief Summary:
This phase I trial is studying the side effects and best dose of ABT-888 when given in combination with temozolomide in treating young patients with recurrent or refractory CNS tumors. ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with temozolomide may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerated dose (MTD) of ABT-888 in combination with temozolomide in children with recurrent or refractory CNS tumors.
II. To study the plasma pharmacokinetics (PK) of ABT-888 and PARP inhibition in peripheral blood mononuclear cells (PBMC) in order to recommend a Phase 2 dose of ABT-888 in combination with temozolomide in children with recurrent or refractory CNS tumors.
III. To describe the toxicities of the combination of ABT-888 and temozolomide in children with recurrent or refractory CNS tumors.
SECONDARY OBJECTIVES:
I. To measure non-homologous end-joining (NHEJ) activity in peripheral blood mononuclear cells (PBMC) prior to and following ABT-888 administration.
II. To assess PARP expression and/or activity in tumor tissue obtained at either initial diagnosis or relapse.
III. To determine expression and/or activity of DNA repair pathways, including MGMT and mismatch repair, in tumor tissues, when available.
IV. To document, within the confines of this phase 1 trial, radiographic tumor response to ABT-888 and temozolomide.
OUTLINE: This is a dose-escalation study of ABT-888.
Patients receive oral ABT-888 twice daily and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for 13-26 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected for pharmacokinetics and further laboratory analysis.
I. To estimate the maximum tolerated dose (MTD) of ABT-888 in combination with temozolomide in children with recurrent or refractory CNS tumors.
II. To study the plasma pharmacokinetics (PK) of ABT-888 and PARP inhibition in peripheral blood mononuclear cells (PBMC) in order to recommend a Phase 2 dose of ABT-888 in combination with temozolomide in children with recurrent or refractory CNS tumors.
III. To describe the toxicities of the combination of ABT-888 and temozolomide in children with recurrent or refractory CNS tumors.
SECONDARY OBJECTIVES:
I. To measure non-homologous end-joining (NHEJ) activity in peripheral blood mononuclear cells (PBMC) prior to and following ABT-888 administration.
II. To assess PARP expression and/or activity in tumor tissue obtained at either initial diagnosis or relapse.
III. To determine expression and/or activity of DNA repair pathways, including MGMT and mismatch repair, in tumor tissues, when available.
IV. To document, within the confines of this phase 1 trial, radiographic tumor response to ABT-888 and temozolomide.
OUTLINE: This is a dose-escalation study of ABT-888.
Patients receive oral ABT-888 twice daily and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for 13-26 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected for pharmacokinetics and further laboratory analysis.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: