Clinical trial · Interventional
Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia
NCT00003688CI-TRIAL-00010672completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gestational Trophoblastic Tumor | Gestational Trophoblastic Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dactinomycin | Biological | Dactinomycin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 12 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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:
* Less than 10% fall in beta-human chorionic gonadotropin (HCG) over 3 consecutive weekly titers
* More than 20% rise in beta-HCG over the previous value at any time
* Rise in beta-HCG (greater than 5 mU/mL) after attaining normal level
* Prior treatment limited to methotrexate (MTX) with or without leucovorin calcium (CF)
* WHO score 2-6 at time of relapse
* Must have undergone at least 1 prior curettage for diagnosis and initial management
* No metastatic disease other than lung or vagina on physical examination, chemistry, chest x-ray, or ultrasound
* No more than 8 metastatic lesions
* No histologically confirmed placental site trophoblastic tumor at initial evaluation
PATIENT CHARACTERISTICS:
Age
* 12 to 50
Performance status
* GOG 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Granulocyte count at least 1,500/mm\^3
Hepatic
* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
* Alkaline phosphatase no greater than 3 times normal
Renal
* Creatinine no greater than 1.5 mg/dL
Other
* No significant infection
* No more than 1 year since prior pregnancy
* Fertile patients must use effective contraception
* No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 1 week since prior chemotherapy and recovered
* No prior chemotherapeutic drugs other than MTX with or without CF
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
* Recovered from prior surgery
* No concurrent curettage unless required to control vaginal bleeding
Other
* No prior anticancer treatment that would preclude study therapyReferences
Publications (1)
- RESULTCovens A, Filiaci VL, Burger RA, Osborne R, Chen MD; Gynecologic Oncology Group. Phase II trial of pulse dactinomycin as salvage therapy for failed low-risk gestational trophoblastic neoplasia: a Gynecologic Oncology Group study. Cancer. 2006 Sep 15;107(6):1280-6. doi: 10.1002/cncr.22118. PMID 16900525