Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003688
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
1999-11-01
Brief Title:
Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia
Status:
COMPLETED
Status Verified Date:
2003-12
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of dactinomycin in treating patients who have persistent or recurrent gestational trophoblastic neoplasia
PURPOSE Phase II trial to study the effectiveness of dactinomycin in treating patients who have persistent or recurrent gestational trophoblastic neoplasia
Detailed Description:
OBJECTIVES
Determine the efficacy of dactinomycin in patients with persistent or recurrent low-risk gestational trophoblastic neoplasia
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive dactinomycin IV over 15 minutes on day 1 Treatment repeats every 2 weeks in the absence of unacceptable toxicity Patients who achieve normal beta-human chorionic gonadotropin HCG receive 2 additional courses after attaining normal beta-HCG
Patients are followed every 2 weeks for 2 months and then monthly for 10 months
PROJECTED ACCRUAL A total of 15-35 patients will be accrued for this study within 18-42 months
Determine the efficacy of dactinomycin in patients with persistent or recurrent low-risk gestational trophoblastic neoplasia
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive dactinomycin IV over 15 minutes on day 1 Treatment repeats every 2 weeks in the absence of unacceptable toxicity Patients who achieve normal beta-human chorionic gonadotropin HCG receive 2 additional courses after attaining normal beta-HCG
Patients are followed every 2 weeks for 2 months and then monthly for 10 months
PROJECTED ACCRUAL A total of 15-35 patients will be accrued for this study within 18-42 months
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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-176 | None | None | None |