Rescue Regimen and High Dose Methotrexate in Management of Presistent Gestational Trophoplastic Neoplasia

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Gestational trophoblastic neoplasia (GTN) are malignant lesions that arise from abnormal proliferation of placental trophoblast. The pathologic conditions that make up this entity include invasive partial and complete hydatidiform mole, choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT). GTN often arises after molar pregnancies but can also occur after any gestation including miscarriages and term pregnancies. In the United States, hydatidiform moles are observed in approximately 1/600 therapeutic abortions and 1/1000-2000 pregnancies . Most cases of GTN are diagnosed when the serum hCG levels plateau or rise in patients being observed after the diagnosis of hydatidiform mole.These malignancies are highly susceptible to chemotherapy and it is often possible to achieve cure while preserving the woman's reproductive function

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Folic Acid; Leucovorin; Levoleucovorin; Methotrexate

Criteria

Inclusion Criteria:

• Age: 18-50

• BW: 50-100 kg

• willing and consenting to be enrolled in the study

• Absence of active vaginal bleeding which requires surgical intervention • - WHO score <6

Exclusion Criteria:

• Renal and liver dysfunction or blood dyscariasis

• high risk persistent gestational trophoblastic disease.