177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma

Description

This is a single arm trial with one Cohort for people with recurrent or metastatic adenoid cystic carcinoma that cannot be treated with surgery. 10 participants will be enrolled in Cohort 1 at Johns Hopkins and will undergo DCFPyL PET/CT and 177Lu-PSMA dosimetry imaging only (single tracer dose). A feasibility analysis of dosimetry will be performed after meeting the accrual goal of Cohort 1 to determine if the study will proceed into Cohort 2. If Cohort 2 proceeds, based on the dosimetry analysis, the major requirements of the study are to undergo treatment with 177Lu-PNT2002, have bloodwork, physical exams, and imaging done at study-specific time points, and to answer questionnaires. Patients will be in the study for about two years after enrolling.

Conditions

Adenoid Cystic Carcinoma

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Study Overview

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Study Details

Study overview

This is a single arm trial with one Cohort for people with recurrent or metastatic adenoid cystic carcinoma that cannot be treated with surgery. 10 participants will be enrolled in Cohort 1 at Johns Hopkins and will undergo DCFPyL PET/CT and 177Lu-PSMA dosimetry imaging only (single tracer dose). A feasibility analysis of dosimetry will be performed after meeting the accrual goal of Cohort 1 to determine if the study will proceed into Cohort 2. If Cohort 2 proceeds, based on the dosimetry analysis, the major requirements of the study are to undergo treatment with 177Lu-PNT2002, have bloodwork, physical exams, and imaging done at study-specific time points, and to answer questionnaires. Patients will be in the study for about two years after enrolling.

A Phase 2, Single-Arm, Multi-center Study of 177Lu-PSMA (177Lu-PNT2002) in Patients With PSMA-Positive Adenoid Cystic Carcinoma

177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma

Condition
Adenoid Cystic Carcinoma
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histologic confirmation of ACC (primary or metastatic tumor). Central review not required but local pathology review required (at Johns Hopkins or Stanford).
  • * Patients must have recurrent or metastatic ACC with measurable disease per RECIST 1.1, not amenable to definitive surgery or radiotherapy.
  • * Patients must have at least 1 lesion positive on PSMA-PET, as defined by standard uptake value (SUV) ratio of tumor to liver greater than one.
  • * Patient can have any or no prior systemic therapies.
  • * At least 28 days must have elapsed between last anti-cancer treatment administration and the initiation of study treatment, or at least 5 half-lives of the prior systemic therapy must have elapsed (whichever is shorter).
  • * Patient must have resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤ 2.
  • * Patient must be ≥ 18 years of age.
  • * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • * Patient must have the ability to understand and the willingness to sign a written informed consent document.
  • * Spinal cord compression or impending spinal cord compression.
  • * Suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis).
  • * Unable to lie flat during or tolerate PET/CT.
  • * Refusal to sign informed consent.
  • * Any medical comorbidities that might preclude safe participation in the study.
  • * Adequate bone marrow reserve and organ function as demonstrated by complete blood count and chemistry panel completed within the prior 28 days demonstrating:
  • 1. Platelet count of \>100 x109/L
  • 2. White blood cell (WBC) count \> 3,000/mL
  • 3. Neutrophil count of \> 1,500/mL
  • 4. Hemoglobin ≥ 10 g/dL
  • 5. Estimated glomerular filtration rate (eGFR) \> 50 mL/min based upon Chronic Kidney Disease- Epidemiology Collaboration (CKD-EPI) equation. Due to safety concerns relating to renal clearance and toxicity of 177Lu-PSMA, patients with estimated GFR between 50 - 60 mL/min will require a 99mTc-TPA GFR test and only patients with non-obstructive pathology will be included in the study.
  • 6. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤5 x upper limit of normal (ULN), total bilirubin \< 3 x ULN
  • 7. Total bilirubin \< 3 x ULN (except if confirmed history of Gilbert's disease)
  • 8. Serum albumin \> 30 g/L
  • * Inadequate bone marrow reserve and organ function as detailed in eligibility criteria.
  • * Patient is participating in a concurrent investigative treatment protocol involving radiotherapy, surgery, or systemic anti-cancer agents.
  • * Patient receiving any other investigational agents.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,

Ana Kiess, MD, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2035-02