Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053950
Status:
TERMINATED
Last Update Posted:
2013-04-09
First Post:
2003-02-05
Brief Title:
Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With High-Risk Neuroblastoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of High-dose Pyrazoloacridine PZA NSC 366140 Supported With Autologous Hematopoietic Stem Cell Rescue in Children With Recurrent or Resistant Neuroblastoma IND 36325
Status:
TERMINATED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
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 pyrazoloacridine given together with peripheral stem cell or bone marrow transplantation in treating young patients with high-risk neuroblastoma Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of PZA given as a single prolonged infusion 6 hours with autologous hematopoietic stem cell aHSC support to children with high risk neuroblastoma with recurrent or refractory disease
II To determine the dose limiting toxicity DLT of PZA given on this schedule
III To characterize the pharmacokinetics of PZA given on this schedule
SECONDARY OBJECTIVES
I To obtain preliminary data on the antitumor activity of PZA within the confines of a Phase I study
II To determine the TP53 mutation status of tumor cells in bone marrow if 10 are present to evaluate expression of p53 and MDM2 proteins by flow cytometry if 01 to 10 are present at study entry
OUTLINE This is a two-stage dose-escalation study
Patients without adequate cryopreserved hematopoietic stem cells undergo peripheral blood stem cell harvest or bone marrow harvest for autologous stem cells at least 2 weeks before study therapy
Patients receive high-dose pyrazoloacridine PZA IV on day 0
Cohort 1 Groups of 3-6 patients receive escalating doses of PZA at a fixed infusion time until the maximum tolerated dose MTD is determined
Cohort 2 Groups of 3-6 patients receive PZA at the dosehour established in cohort I at escalating infusion times until another MTD is determined
In both cohorts the MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients receive filgrastim G-CSF IV or subcutaneously beginning on day 4 and continuing until blood counts recover Patients also undergo reinfusion of stem cells over 15-30 minutes on day 4 as needed per protocol
Patients are followed at days 28-35 every 3 months for 3 years and then every 6 months thereafter
I To determine the maximum tolerated dose MTD of PZA given as a single prolonged infusion 6 hours with autologous hematopoietic stem cell aHSC support to children with high risk neuroblastoma with recurrent or refractory disease
II To determine the dose limiting toxicity DLT of PZA given on this schedule
III To characterize the pharmacokinetics of PZA given on this schedule
SECONDARY OBJECTIVES
I To obtain preliminary data on the antitumor activity of PZA within the confines of a Phase I study
II To determine the TP53 mutation status of tumor cells in bone marrow if 10 are present to evaluate expression of p53 and MDM2 proteins by flow cytometry if 01 to 10 are present at study entry
OUTLINE This is a two-stage dose-escalation study
Patients without adequate cryopreserved hematopoietic stem cells undergo peripheral blood stem cell harvest or bone marrow harvest for autologous stem cells at least 2 weeks before study therapy
Patients receive high-dose pyrazoloacridine PZA IV on day 0
Cohort 1 Groups of 3-6 patients receive escalating doses of PZA at a fixed infusion time until the maximum tolerated dose MTD is determined
Cohort 2 Groups of 3-6 patients receive PZA at the dosehour established in cohort I at escalating infusion times until another MTD is determined
In both cohorts the MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients receive filgrastim G-CSF IV or subcutaneously beginning on day 4 and continuing until blood counts recover Patients also undergo reinfusion of stem cells over 15-30 minutes on day 4 as needed per protocol
Patients are followed at days 28-35 every 3 months for 3 years and then every 6 months thereafter
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NANT N2002-01 | None | None | None |
| P01CA081403 | NIH | None | None |
| CHLA-NANT-N2002-01 | None | None | None |
| CDR0000269644 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01CA081403 |