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

NCT03280979 | Unknown Phase 2

• 1 other identifier: RR&HDMPGTN
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Gestational Trophoblastic Disease

Outcome Measures

Primary Outcomes (1)

• cure rate

  cure rate till B hcG is negative and then 2 consolidation regimens

  12 month

Secondary Outcomes (1)

• decline in Bhcg

  12 month

Study Arms (2)

study group1

EXPERIMENTAL

In the rescue regimen , we administer MTX in an eight-day treatment regimen consisting of four administrations of MTX given at 1 mg/kg I.M. every other day with folinic acid 0.1 mg/kg I.M,. given on intervening days.

Drug: rescue regimen

study group2

EXPERIMENTAL

In the high dose MTX protocol, the patients will receive 100 mg/m2 intravenous (IV) MTX bolus followed by 200 mg/m2IV MTX infused over 12 hours followed by folinic acid

Drug: high dose methotrxate

Interventions

rescue regimen DRUG

In the rescue regimen , we administer MTX in an eight-day treatment regimen consisting of four administrations of TX given at 1 mg/kg I.M. every other day with folinic acid 0.1 mg/kg I.M,. given on intervening days.

study group1

high dose methotrxate DRUG

In the high dose MTX protocol, the patients will receive 100 mg/m2 intravenous (IV) MTX bolus followed by 200 mg/m2IV MTX infused over 12 hours followed by folinic acid

study group2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Renal and liver dysfunction or blood dyscariasis
• high risk persistent gestational trophoblastic disease.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Gestational Trophoblastic Disease

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

zahraa magdy, md

CONTACT

01002603379; zahraamagdy92@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: October 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL