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Radioisotope Therapy
177Lu-PSMA for Cancer
Phase 2
Waitlist Available
Led By Ana Kiess, MD, PhD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is for people with a specific type of cancer that has come back or spread and cannot be removed with surgery. The trial will involve 10 participants at Johns Hopkins who will undergo imaging tests to
Who is the study for?
This trial is for people with recurrent or metastatic adenoid cystic carcinoma that's not suitable for surgery. Participants will be part of a study at Johns Hopkins, undergoing special imaging and possibly treatment with the drug 177Lu-PNT2002 if they move to Cohort 2 after initial assessments.
What is being tested?
The trial is testing the use of a radioactive drug called 177Lu-PNT2002 in patients with specific cancer. Initially, participants undergo diagnostic imaging; if results are favorable, they may receive the actual treatment in Cohort 2.
What are the potential side effects?
Potential side effects aren't specified here but generally, radioactive drugs like 177Lu-PSMA can cause nausea, dry mouth, fatigue, and temporary changes in blood counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Absorbed dose in tumor and normal organs
Objective response rate (ORR) by RECIST 1.1 measured in patients treated with 177Lu-PSMA for recurrent and metastatic ACC.
Secondary study objectives
Duration of Response
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43)
Overall Survival
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SPECT CT DosimetryExperimental Treatment1 Intervention
Absorbed dose in tumor and normal organs will by measured using SPECT/CT dosimetry in Cohort 1.
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Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
571 Previous Clinical Trials
33,321 Total Patients Enrolled
Adenoid Cystic Carcinoma Research FoundationOTHER
6 Previous Clinical Trials
151 Total Patients Enrolled
Progenics Pharmaceuticals, Inc.Industry Sponsor
34 Previous Clinical Trials
4,378 Total Patients Enrolled
Ana Kiess, MD, PhDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
80 Total Patients Enrolled