To evaluate the safety and efficacy of 177Lu-PSMA RLT in patients with R/M ACC and SDC with PSMA ligand uptake.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety
Secondary outcome
- Efficacy: by objective response rate (ORR)
- Progression free survival (PFS)
- Overal survival (OS)
- Duration of response (DoR)
- Quality of life (QoL)
- delivered dose
- radiation toxicity
- to explore differences in tumor mutational burden, immunohistochemical
expression profiles and intracellular pathways between responding and
non-responding patients
Background summary
Salivary gland cancer (SGC) is one of the rare cancers. Treatment options for
incurative local or regional recurrences and/or metastatic (R/M) SGC are
limited and therefore new treatment options are urgently needed.
Radioligand therapy (RLT) is a promising new therapeutic approach to treat
advanced prostate cancer. Lutetium-177 (177Lu, β-emitter) labelled PSMA is a
highly effective treatment directed against prostate-specific membrane antigen
(PSMA), which is overexpressed in prostate cancer cells. A previous imaging
study showed there is also PSMA expression in two frequently occurring subtypes
of SGC: adenoid cystic carcinoma (ACC) and salivary duct carcinoma (SDC).
Therefore we consider 177Lu-PSMA RLT a potential new treatment option for these
subtypes of SGC.
Study objective
To evaluate the safety and efficacy of 177Lu-PSMA RLT in patients with R/M ACC
and SDC with PSMA ligand uptake.
Study design
Phase II pilot study, single centre, two cohorts.
Cohort 1: Patients with R/M ACC, 4 cyles of 7.4 GBq 177Lu-PSMA every 6 weeks.
Cohort 2: Patients with R/M SDC, 4 cyles of 7.4 GBq 177Lu-PSMA every 6 weeks.
Intervention
Repeated intravenous application of 7.4 GBq (gigabequerel)(±10%) 177Lu-PSMA
every 6±1 weeks; until reaching four cycles.
Study burden and risks
Burden and risks: During the 3 years of the study, patients will make
approximately 30 study related visits. 5 PET-CT, 5 SPECT-CT and 10 CT scans
will be made. During outpatient visits blood samples will be taken for safety
assessments together with additional blood samples for research purposes (e.g.
pharmacokinetic studies, response assessment). Patients will be asked to fill
in questionnaires 6 times.
A potential risk is the therapeutic injection with 177Lu-PSMA itself, as it is
not yet completely clear what the short and long-term toxicity profile of this
new therapeutic approach is. However in patients with prostate cancer this
therapy is relatively well-tolerable with low side-effect profile.
Benefit: Treatment with 177Lu-PSMA could lead to response or stabilize
previously progressive disease and therefore potentially prolong survival. It
may improve the quality of life of patients whom experience any kind of
discomfort due to the progression of their disease
Geert Grooteplein Zuid 8
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 8
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
- Patients must have the ability to provide written informed consent.
- Patients must be >= 18 years of age.
- Patients must have an ECOG performance status of 0 to 2.
- Patients must have histological, pathological, and/or cytological
confirmation of either adenoid cystic carcinoma or salivary duct carcinoma.
- Patients must have incurable, local or regional recurrent or metastatic ACC
or SDC.
- Patients with ACC can only participate in case of objective growth in the
last three months or complaints due to the disease.
- Patients must have adequate organ function:
Sufficient bone marrow capacity as defined by: WBC count (white blood cell)
>=2.5x10^9/L, PLT (platelet) count >=100x10^9/L, Hb >=6 mmol/L, absolute
neutrophil count (ANC) >=1.5x10^9/L
Adequate liver function as defined by: Total bilirubin <=1.5 x ULN. For
patients known with Gilbert*s Syndrome <= 3 x ULN is permitted. Alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) <=3.0 × ULN OR <=5.0
× ULN for patients with liver metastases.
Adequate kidney function as defined by: Serum creatinine <=1.5 x ULN or
creatinine clearance >= 50 mL/min
- Patients must have measurable disease at baseline. Defined as >= 1 lesion >= 2
cm (long axis) that is present on baseline CT.
- Patients must have a positive 68Ga-PSMA PET/CT scan, defined by at least one
lesion >= 1.5 cm (long axis) with a ligand uptake above liver level.
Exclusion criteria
- Patients whom are pregnant or breast feeding.
- Patients with reproductive potential not implementing adequate contraceptives
measures.
- Patients with known brain metastases or cranial epidural disease or
intracardial metastases.
- Patients with concurrent serious (as determined by the Principal
Investigator) medical conditions, including, but not limited to, New York Heart
Association class III or IV congestive heart failure, history of congenital
prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or
other significant comorbid conditions that in the opinion of the investigator
would impair study participation or cooperation.
- Patients with urinary tract obstruction or marked hydronephrosis
- Less than 4 weeks since last myelosuppressive therapy or other radionuclide
therapy.
- Concomitant cancer treatments
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003857-27-NL |
| CCMO | NL71624.091.19 |