Natural Progesterone for the Treatment of Recurrent Glioblastoma

Status Recruiting

Clinical Trial Summary

This early phase I trial identifies the best dose, possible benefits and/or side effects of natural progesterone in treating patients with glioblastoma that has come back (recurrent). Progesterone is a type of hormone made by the body that plays a role in the menstrual cycle and pregnancy. Progesterone may help control tumor growth and spread in patients with glioblastoma.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine that the pharmacokinetics of natural progesterone given to recurrent glioblastoma [GBM] patients by subcutaneous injection is consistent with previous determinations made given subcutaneously using the aqueous formulation of progesterone. II. To determine the safety of administering daily subcutaneous natural progesterone for the treatment of patients with recurrent GBMs. III. To determine the rate of stable disease (SD) or better (partial response [PR] or complete response [CR]) at 8 weeks in eligible patients with recurrent GBM treated with daily subcutaneous natural progesterone. SECONDARY OBJECTIVES: I. To determine and compare the progression free survival of eligible patients with recurrent GBM compared with matched historical controls treated with a range of standard therapies. II. To determine and compare the overall survival of eligible patients with recurrent GBM compared with matched historical controls treated with a range of standard therapies. EXPLORATORY OBJECTIVES: I. To determine whether progesterone receptor levels within the tumor correlates with response to daily subcutaneous natural progesterone. II. To determine if other intrinsic tumor factors (mutations and genomic loss/gains) correlates with response to daily subcutaneous natural progesterone. III. To determine if the absolute values or changes in the level of serum biomarkers correlates with response to daily subcutaneous natural progesterone. IV. To determine the quality-of-life (QOL) by validated instruments of eligible patients with recurrent GBM treated with daily subcutaneous natural progesterone and assess whether this differs from historical controls. OUTLINE: Patients receive progesterone subcutaneously (SC) once daily (QD) for up to 24 weeks in the absence of disease progression or unacceptable toxicity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05091866
Study type	Interventional
Source	Emory University
Contact
Status	Recruiting
Phase	Early Phase 1
Start date	April 11, 2022
Completion date	August 25, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05577091` - Tris-CAR-T Cell Therapy for Recurrent Glioblastoma	Phase 1
Recruiting	`NCT05284643` - Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma	N/A
Recruiting	`NCT05039281` - Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma	Phase 1/Phase 2
Recruiting	`NCT04988750` - Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients	N/A
Recruiting	`NCT06058988` - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer	Phase 2
Completed	`NCT00503204` - Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour	Phase 1
Completed	`NCT03216499` - HIF-2 Alpha Inhibitor PT2385 in Treating Patients With Recurrent Glioblastoma	Phase 2
Not yet recruiting	`NCT04717999` - Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent Glioblastoma	N/A
Not yet recruiting	`NCT05540275` - Tislelizumab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for Bevacizumab Refractory Recurrent Glioblastoma	Phase 2
Recruiting	`NCT04528680` - Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma	Phase 1/Phase 2
Active, not recruiting	`NCT04044937` - Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms	Phase 2
Recruiting	`NCT04888611` - Neoadjuvant PD-1 Antibody Alone or Combined With DC Vaccines for Recurrent Glioblastoma	Phase 2
Completed	`NCT00390299` - Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme	Phase 1
Recruiting	`NCT05463848` - Surgical Pembro +/- Olaparib w TMZ for rGBM	Phase 2
Active, not recruiting	`NCT04479241` - LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma	Phase 2
Active, not recruiting	`NCT00777153` - Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma	Phase 3
Withdrawn	`NCT05017610` - Inducing a Hypothyroxinemic State in Patients With Recurrent Glioblastoma or Gliosarcoma	Early Phase 1
Recruiting	`NCT04323046` - Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults	Phase 1
Active, not recruiting	`NCT05324501` - A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma	Phase 1
Withdrawn	`NCT05666349` - Reirradiation and Niraparib in Patients With Recurrent Glioblastoma	Phase 1