Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT00053950
Status:
TERMINATED
Last Update Posted:
2013-04-09
First Post:
2003-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With High-Risk Neuroblastoma
Sponsor:
National Cancer Institute (NCI)
Organization:
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 \>= 0.1% 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 dose/hour 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 \>= 0.1% 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 dose/hour 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:
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NANT N2002-01 | None | None | View | |
| P01CA081403 | NIH | None | https://reporter.nih.gov/quic… | View |
| CHLA-NANT-N2002-01 | None | None | View | |
| CDR0000269644 | None | None | View |