A Phase 2 interventional study of dactinomycin in Gestational Trophoblastic Tumor, sponsored by Gynecologic Oncology Group. Completed at 29 sites in 2 countries. Open to female participants aged 12 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-06-10.
Sponsored by Gynecologic Oncology Group · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
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.
46 studies on the registry are indexed under Trophoblastic Neoplasms; 7 are open to participants now.
Browse Trophoblastic Neoplasms studies →Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed complete or partial mole on initial evaluation
Current diagnosis of persistent or recurrent low-risk gestational trophoblastic neoplasia, defined by 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
This study is completed, as verified in Dec 2003. You cannot join it, but the record below documents what was studied.
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Gynecologic Oncology Group