BrUOG 263: Prostate Specific Membrane Antigen (PSMA) Glioblastoma Multiforme (GBM)

NCT01856933 | Completed Phase 2 Results DMC

• 1 other identifier: 263
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the effectiveness of Prostate Specific Membrane Antigen (PSMA ADC), as well as its safety and side effects for patients with advanced brain tumors. This study will also study how your body metabolizes (breaks down) PSMA ADC.

Conditions

GBM; Glioblastoma Multiforme; Gliosarcoma

Keywords

GBM; Glioblastoma Multiforme; Gliosarcoma

Outcome Measures

Primary Outcomes (1)

• Response Rate (Progression) for Patients With Glioblastoma That Have Progressed After Prior Treatment That Has Included Radiation, Temozolomide and Bevacizumab.

  The response assessment in neuro-oncology (RANO) will be used to define radiographic response. (PD): A \>25% increase in tumor area (product of two diameters) OR appearance of a new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

  3 months until progression, potentially up to 1 year

Secondary Outcomes (1)

• Number of Patients Who Experienced Toxicities (Adverse Events) Who Received PSMA ADC for Recurrent Glioblastoma.

  at least every 3 weeks for a maximum of 30 post coming off drug, approximately 6 months

Study Arms (1)

PSMA ADC

EXPERIMENTAL

2.5 mg/kg, IV, over 60 minutes every 3 weeks

Drug: PSMA ADC

Interventions

PSMA ADC DRUG

2.5 mg/kg, IV, over 60 minutes every 3 weeks

PSMA ADC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females Histologically confirmed GBM (Patients with gliosarcoma are also eligible)
• Assessable or measurable disease by MRI
• Progression after prior treatment that includes radiation, temozolomide and bevacizumab.
• \> 4 weeks since prior chemotherapy, bevacizumab and other systemic treatment and \> 3 weeks from prior radiation.
• age \>18 years
• Weight \< 150 kg.
• Karnofsky performance score \> 60
• Life expectancy \>12 weeks
• Brain MRI within 21 days prior to registration
• Laboratory results requirements
• Absolute neutrophil count (ANC) ≥ 1000/mm3.
• Platelets (Plt) ≥ 100,000/mm3
• Hemoglobin (Hgb) ≥ 8.0 g/dL
• Total bilirubin ≤ 2.0 mg/dL
• Serum alanine transferase/ Serum aspartate transaminase (ALT/AST) ≤ 2.5x the upper limit of normal (ULN)

You may not qualify if:

• Non-GBM primary invasive malignant neoplasm within the five years prior to screening except for:
• keratinocyte (non-melanoma) (i.e., basal cell, squamous cell) carcinoma of the skin; or low-grade papillary superficial transitional cell carcinoma of the bladder.However, patients with stage 1 cancers not requiring cancer therapy including chemotherapy or hormone therapy, for which a lifespan of greater than 3 years without treatment is expected (such as early stage prostate cancer) may be enrolled.
• Clinically significant cardiac disease (New York Heart Association Class III/ IV or severe debilitating pulmonary disease
• Subjects with QTc\>500 msec (either Bazzett's or Fridericia's method)
• Radiation therapy, cytotoxic chemotherapy, bevacizumab or other treatment for GBM within previous three weeks
• Evidence of an active infection requiring ongoing intravenous antibiotic therapy
• Any toxicity ≥ grade 2 (non-laboratory) (NCI CTCAE, Version 4.03) prior to first dose of study drug
• Prior treatment with PSMA ADC or other therapies targeting PSMA, or other anti-body drug conjugate (ADC) products that contain monomethyl auristatin E (MMAE) (e.g., brentuximab vedotin, glembatumumab vedotin, ASG-5ME)
• Known hypersensitivity reactions to PSMA ADC or any of its components.
• Any medical condition that in the opinion of the Investigator may interfere with a subject's participation in or compliance with the study
• Patients with a prior history of pancreatitis

Sponsors & Collaborators

• Heinrich Elinzano, MD: lead
• Progenics Pharmaceuticals, Inc.: collaborator
• Rhode Island Hospital: collaborator
• University of Texas: collaborator

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

UT Southwestern

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma

Interventions

PSMA ADC

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Heinrich Elinzano, MD
• Organization: Brown University Oncology Research Group (BrUOG)

kayla_rosati@brown.edu

4018633000

Study Officials

• Heinrich Elinzano, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: May 20, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2015
• Last Updated: November 23, 2021
• Results First Posted: June 17, 2015

Record last verified: 2021-11

Locations

US (2)