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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
Female
Gestational Trophoblastic Tumor

Thank you

Trial Information

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


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.

Inclusion Criteria


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 therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Allan Covens, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Odette Cancer Centre at Sunnybrook

Authority:

United States: Federal Government

Study ID:

CDR0000066791

NCT ID:

NCT00003688

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

Name

Location

MBCCOP - HawaiiHonolulu, Hawaii  96813
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Community Hospital of Los GatosLos Gatos, California  95032
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
University of Texas Medical BranchGalveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Cooper University HospitalCamden, New Jersey  08103
Tufts - New England Medical CenterBoston, Massachusetts  02111
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Abramson Cancer Center at University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182