Status:
COMPLETED
BrUOG 263: Prostate Specific Membrane Antigen (PSMA) Glioblastoma Multiforme (GBM)
Lead Sponsor:
Heinrich Elinzano, MD
Collaborating Sponsors:
Progenics Pharmaceuticals, Inc.
Rhode Island Hospital
Conditions:
GBM
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
PSMA expression has been demonstrated in the tumor neovasculature of Glioblastoma Multiforme (GBM) by immunohistochemical staining. Strong reactivity to the antibody component of PSMA ADC was observed...
Eligibility Criteria
Inclusion
- 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)
- Serum creatinine ≤ 2.0 mg/dL
- Pancreatic Amylase (p-amylase) ≤ the ULN
- Negative serum pregnancy test for women of child-bearing potential
- Stable corticosteroid dose at least 14 days prior to registration
- Women of childbearing potential must have a negative pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- Patients must not be on enzyme-inducing anti-epileptic drugs (EIAED). Patients may be on non-enzyme inducing anti-epileptic drugs (NEIAED) or may not be taking any anti-epileptic drugs. A list of AED that cause modest or no induction of hepatic metabolic enzymes will be discussed
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01856933
Start Date
May 1 2013
End Date
February 1 2015
Last Update
November 23 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
2
UT Southwestern
Dallas, Texas, United States, 75235