Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Recurrence

Trophoblastic Neoplasms

Gestational Trophoblastic Disease

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Pregnancy Complications

Pregnancy Complications, Neoplastic

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Gestational Trophoblastic Tumor

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Dactinomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

dactinomycin

Allan Covens, MD

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:

* 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.

Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

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

National Cancer Institute (NCI)

Gynecologic Oncology Group

Hydatidiform Mole

Micronutrients

Hematinics

Vitamins

Pemetrexed

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

pemetrexed disodium

David S. Miller, MD

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent low-risk gestational trophoblastic tumor after a molar pregnancy.

OBJECTIVES:

* Determine the activity of pemetrexed disodium as salvage therapy in patients with persistent or recurrent low-risk post-molar gestational trophoblastic tumor that failed prior dactinomycin or methotrexate.
* Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression or until tumor marker levels (human chorionic gonadotropin \[hCG\]) become normal. Patients receive 2 additional courses beyond the attainment of a normal hCG.

Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.

Patients are followed every 2 weeks for 2 months and then monthly for 10 months.

PROJECTED ACCRUAL: Approximately 17-55 patients will be accrued for this study within 20-50 months.

Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy

A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia	NCT00003688	Gestational Tro...	dactinomycin	12 Years - 50 Years	GOG Foundation
Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy	NCT00096187	Gestational Tro...	pemetrexed diso...	- 120 Years	GOG Foundation
Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy	NCT00096187	Gestational Tro...	pemetrexed diso...	- 120 Years	GOG Foundation

Spots Global Cancer Trial Database for low risk metastatic gestational trophoblastic tumor