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Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia Clinical research trials and Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia. Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia clinical trial. Participants typically obtain the most effective healthcare available for their Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia  Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
For Condition: nonmetastatic gestational trophoblastic tumor,good prognosis metastatic gestational trophoblastic tumor,recurrent gestational trophoblastic tumor
Status: No longer recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: 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 recurrentgestational trophoblastic neoplasia.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/50 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AllanCovens, Study Chair, Toronto Sunnybrook Regional Cancer Centre
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1065
United States
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, 92868
United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1009
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Ireland Cancer Center
Cleveland, Ohio, 44106
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0526
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, 11794-8091
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-3236
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Cooper University Hospital
Camden, New Jersey, 08103-1489
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Additional Information:
Study ID Numbers: CDR0000066791; GOG-176
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003688
Other Nonmetastatic Gestational Trophoblastic Tumor Studies:
1. Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
2. Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
Related Studies:
Other nonmetastatic gestational trophoblastic tumor Clinical Trials
Other Texas Clinical Trials
Other Galveston Clinical Trials
Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
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