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Trial Title:
177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma
NCT ID:
NCT06322576
Condition:
Adenoid Cystic Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Adenoid Cystic
Conditions: Keywords:
Lutetium-177
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Cohort 1of this study involves only Dosimetry for (10 patients).
(Cohort 2 may be added based on dosimetry analysis of Cohort 1. Planned Treatment for
would be for 20 patients, single arm).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
177Lu-PNT2002
Description:
10 patients will undergo DCFPyL PET/CT and 177Lu-PSMA dosimetry imaging only (single
tracer dose).
If opened, Cohort 2 patients will receive 4 cycles, every 8 weeks of 177Lu-PSMA infusion.
Other procedures during treatment and follow up may include: physical exam, CT/MRI,
PSMA-PET, blood draws, adverse event assessment, and completion of questionnaires.
Arm group label:
SPECT CT Dosimetry
Other name:
177Lu PSMA
Summary:
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.
Detailed description:
Malignant salivary gland tumors account for approximately 3% to 5% of all head and neck
cancers with approximately 0.4 to 2.6 cases per 100,000 people. Most patients present in
the sixth to seventh decade of life. Adenoid cystic carcinoma (ACC) accounts for about
10% of all tumors of the salivary glands, often arises from the minor and major salivary
glands but can also involve lacrimal and ceruminous glands, as well as other sites in the
head and neck (nasal and paranasal sinuses, trachea, and larynx). Anatomically, ACC
originates from the intercalated duct region and proliferates in three distinct
architectural patterns: tubular, cribriform, and solid.
In the setting of recurrent and metastatic (R/M) ACC, first-line options include
single-agent vinorelbine or mitoxantrone, or cyclophosphamide plus doxorubicin plus
cisplatin (CAP). Overall response rates (ORR) are usually less than 15%. There are no
effective second line options. While epidermal growth factor receptor (EGFR) has been
shown to be overexpressed in some ACC, none of the phase II clinical trials of single
agent cetuximab, gefitinib, or lapatinib demonstrated an objective response. Many cases
of ACC also express the c-kit protein, however, use of single agent imatinib in patients
with c-kit expression confirmed by immunohistochemistry (IHC) failed to produce an
objective response. Phase II single agent sunitinib exhibited no objective response.
Median progression free survival (PFS) of these phase II trials ranged from 3.5 months to
7.2 months. Ultimately, most patients with R/M ACC die from cancer, highlighting the need
for effective therapies.
The investigators aim to examine and analyze PSMA-PET uptake in ACC to establish whether
it is correlated to absorbed tumor dose and objective response in Cohort 1 participants.
Criteria for eligibility:
Criteria:
Inclusion 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.
For female patients with childbearing potential or male patients with partners of
childbearing potential, agreement to use barrier contraceptive method (condom) and to
continue its use for 6 months from receiving the last dose of 177Lu-PSMA. Female patients
with childbearing potential will undergo a urine pregnancy test. Pregnant female
participants are excluded.
- Patient must have the ability to understand and the willingness to sign a written
informed consent document.
Exclusion Criteria:
- 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.
Additional inclusion criteria only relevant if Cohort 2 participants enrolled:
- 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
Additional exclusion criteria only relevant if Cohort 2 participants enrolled:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Johns Hopkins Hospital
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Start date:
December 2024
Completion date:
December 2035
Lead sponsor:
Agency:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class:
Other
Collaborator:
Agency:
Adenoid Cystic Carcinoma Research Foundation
Agency class:
Other
Collaborator:
Agency:
Progenics Pharmaceuticals, Inc.
Agency class:
Industry
Source:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06322576