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Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia

Phase 2
12 Years
50 Years
Not Enrolling
Gestational Trophoblastic Tumor

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Trial Information

Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia


- 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

Inclusion Criteria


- 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



- 12 to 50

Performance status

- GOG 0-1

Life expectancy

- Not specified


- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Granulocyte count at least 1,500/mm^3


- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal


- Creatinine no greater than 1.5 mg/dL


- 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


Biologic therapy

- Not specified


- 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


- Not specified


- See Disease Characteristics

- Recovered from prior surgery

- No concurrent curettage unless required to control vaginal bleeding


- No prior anticancer treatment that would preclude study therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Allan Covens, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Odette Cancer Centre at Sunnybrook


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Gestational Trophoblastic Tumor
  • recurrent gestational trophoblastic tumor
  • nonmetastatic gestational trophoblastic tumor
  • low risk metastatic gestational trophoblastic tumor
  • Neoplasms
  • Trophoblastic Neoplasms
  • Gestational Trophoblastic Neoplasms



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