Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039481
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2002-06-06
Brief Title:
Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial Of G3139 BCL-2 Antisense NSC 683428 IND 58842 Combined With Cytotoxic Chemotherapy In Relapsed Childhood Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of oblimersen plus combination chemotherapy and dexrazoxane in treating children and adolescents who have relapsed or refractory solid tumors Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Oblimersen may increase the effectiveness of doxorubicin and cyclophosphamide by making the tumor cells more sensitive to the drug Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy
Detailed Description:
OBJECTIVES
I Determine the dose-limiting toxic effects and recommended phase II dose of oblimersen when combined with cyclophosphamide doxorubicin and dexrazoxane in pediatric patients with relapsed or refractory solid tumors
II Determine the pharmacokinetic behavior of this regimen in these patients III Determine preliminarily the antitumor activity of oblimersen in these patients
IV Assess the biologic activity of oblimersen in mononuclear cells and tumor tissues in terms of bcl-2 and related protein expression in these patients
OUTLINE This is a 2-part multicenter dose-escalation study
Part A Patients receive oblimersen IV continuously on days 1-7 Patients also receive dexrazoxane IV followed by doxorubicin IV over 15 minutes followed by cyclophosphamide IV over 1 hour on days 5 and 6 Filgrastim G-CSF is administered subcutaneously once daily beginning on day 8 and continuing until blood counts recover Treatment repeats every 21 days for up to 18 courses 1 year in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease whose shortening fraction falls below 28 by echocardiogram or whose total life-time cumulative anthracycline dose exceeds 750 mgm2 may receive additional courses of oblimersen and cyclophosphamide without doxorubicin and dexrazoxane
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Part B Patients receive oblimersen at the MTD determined in part A and escalating doses of dexrazoxane doxorubicin and cyclophosphamide on the same treatment schedule as in part A
Cohorts of 3-6 patients receive escalating doses of dexrazoxane doxorubicin and cyclophosphamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 12-15 patients will be accrued for this study within 1-2 years
I Determine the dose-limiting toxic effects and recommended phase II dose of oblimersen when combined with cyclophosphamide doxorubicin and dexrazoxane in pediatric patients with relapsed or refractory solid tumors
II Determine the pharmacokinetic behavior of this regimen in these patients III Determine preliminarily the antitumor activity of oblimersen in these patients
IV Assess the biologic activity of oblimersen in mononuclear cells and tumor tissues in terms of bcl-2 and related protein expression in these patients
OUTLINE This is a 2-part multicenter dose-escalation study
Part A Patients receive oblimersen IV continuously on days 1-7 Patients also receive dexrazoxane IV followed by doxorubicin IV over 15 minutes followed by cyclophosphamide IV over 1 hour on days 5 and 6 Filgrastim G-CSF is administered subcutaneously once daily beginning on day 8 and continuing until blood counts recover Treatment repeats every 21 days for up to 18 courses 1 year in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease whose shortening fraction falls below 28 by echocardiogram or whose total life-time cumulative anthracycline dose exceeds 750 mgm2 may receive additional courses of oblimersen and cyclophosphamide without doxorubicin and dexrazoxane
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Part B Patients receive oblimersen at the MTD determined in part A and escalating doses of dexrazoxane doxorubicin and cyclophosphamide on the same treatment schedule as in part A
Cohorts of 3-6 patients receive escalating doses of dexrazoxane doxorubicin and cyclophosphamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 12-15 patients will be accrued for this study within 1-2 years
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 |
|---|---|---|---|
| CDR0000069387 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA097452 |
| ADVL0211 | None | None | None |
| U01CA097452 | NIH | None | None |