Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006102
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2000-08-03
Brief Title:
Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Rebeccamycin Analogue NSC 655649 in Children With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2010-11
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 II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkins lymphoma Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the response in children with solid tumors or non-Hodgkins lymphoma treated with rebeccamycin analogue
II Determine and maintain a plasma concentration of at least 5 µgmL of this drug in these patients
III Determine the toxicity of this drug in these patients IV Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study
Patients with solid tumors are stratified according to tumor histology neuroblastoma vs Ewings sarcoma closed to accrual as of 51903peripheral primative neuroectodermal tumor PNET vs osteosarcoma closed to accrual as of 51903 vs rhabdomyosarcoma vs non-Hodgkins lymphoma vs other solid tumors Patients with CNS tumors are stratified according to tumor histology medulloblastomaPNET vs ependymoma vs brainstem glioma vs other CNS tumors
Patients receive rebeccamycin analogue IV over 1 hour on day 1 Treatment continues every 21 days for a total of 16 courses in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 1 year every 2 months for 2 years every 6 months for 1 year and then annually thereafter
I Determine the response in children with solid tumors or non-Hodgkins lymphoma treated with rebeccamycin analogue
II Determine and maintain a plasma concentration of at least 5 µgmL of this drug in these patients
III Determine the toxicity of this drug in these patients IV Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study
Patients with solid tumors are stratified according to tumor histology neuroblastoma vs Ewings sarcoma closed to accrual as of 51903peripheral primative neuroectodermal tumor PNET vs osteosarcoma closed to accrual as of 51903 vs rhabdomyosarcoma vs non-Hodgkins lymphoma vs other solid tumors Patients with CNS tumors are stratified according to tumor histology medulloblastomaPNET vs ependymoma vs brainstem glioma vs other CNS tumors
Patients receive rebeccamycin analogue IV over 1 hour on day 1 Treatment continues every 21 days for a total of 16 courses in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 1 year every 2 months for 2 years every 6 months for 1 year and then annually 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 |
|---|---|---|---|
| CDR0000068111 | REGISTRY | PDQ Physician Data Query | None |
| COG-P9963 | None | None | None |