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New treatment option for Sinonasal Neuroendocrine Carcinoma
Official title [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers
ClinicalTrials.gov ID: NCT06479811
What this study is testing
What is 68Ga-DOTATATE?
68Ga-DOTATATE is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for sinonasal neuroendocrine carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Some cancers have high levels of proteins called somatostatin receptors (SSTRs) on the surface of the tumors. These tumors can be in the lung, head and neck, digestive tract, kidneys, and in or near the adrenal glands.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Participants must have histopathologically confirmed gastrointestinal neuroendocrine tumors (GI NET), pheochromocytoma/paraganglioma (PPGL), small...
- Required prior therapies:
- GI NET, PPGL, H\&N: no specific prior therapy is needed.
- SCLC: At least one prior line of standard of care systemic treatment such as chemotherapy and/or immunotherapy.
- KC: Renal cell carcinoma (RCC) participants should have received at least one line of prior therapy in the metastatic setting and should have...
You likely can't join if
- Any investigational agents should be stopped at least 28 days prior to the first dose of [203Pb]VMT-Alpha-NET.
- Systemic therapy should be stopped at least 28 days prior to the first dose of [203Pb]VMT-Alpha-NET (participants with prior systemic therapies for...
- Systemic therapy should be stopped at least 14 days prior to the first dose of [203Pb]VMT-Alpha-NET (participants with SCLC only).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to VMT-Alpha-NET.
- Positive Beta human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.
- QTc \> 450 ms on electrocardiogram (EKG) at screening. Note: Framingham correction for QTc will be used
See the full eligibility criteria
- Participants must have histopathologically confirmed gastrointestinal neuroendocrine tumors (GI NET), pheochromocytoma/paraganglioma (PPGL), small cell lung cancers (SCLC), kidney cancers (KC), or Head \& Neck cancers...
- Required prior therapies:
- GI NET, PPGL, H\&N: no specific prior therapy is needed.
- SCLC: At least one prior line of standard of care systemic treatment such as chemotherapy and/or immunotherapy.
- KC: Renal cell carcinoma (RCC) participants should have received at least one line of prior therapy in the metastatic setting and should have received at least one Programmed cell death protein 1 (PD1) / Programmed...
- Have NOT received prior systemic radioligand therapy for definitive therapeutic purposes. Prior external beam radiation therapy is allowed.
- History of disease progression by imaging (e.g., RECIST 1.1) or clinically (defined as increase in severity or frequency of symptoms related to disease) within the past 36 months prior to the first dose of...
- Evidence of somatostatin receptors (SSTR) expression on at least 50% of the radiographically identifiable (i.e., visible on an anatomic scan such as CT or magnetic resonance imaging [MRI]) tumor, as indicated by a...
- Age \>= 18 years.
- ECOG performance status \<=1.
- Participants must have adequate organ and marrow function as defined below:
- Leukocytes: 3,000/microliter
- Absolute Neutrophil Count: 1,500/microliter
- Platelets 100,000/microliter
- Hemoglobin \>= 9.0 g/dL
- Total bilirubin: within normal institutional limits. Note: \<= 5 X institutional upper limit of normal (ULN) if bilirubin elevation is due to a benign process such as Gilbert syndrome
- AST: \<= 2.5 X institutional ULN
- ALT: \<= 2.5 X institutional ULN
- Creatinine: within normal institutional limits OR
- Calculated creatinine clearance (glomerular filtration rate (eGFR): \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal
- Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression at screening.
- Participants with new or progressive brain metastases or leptomeningeal disease are eligible as long as the participant is asymptomatic and not requiring medication for symptom control from the brain lesions at...
- Participants seropositive for human immunodeficiency virus (HIV) must:
- be on effective anti-retroviral therapy; and
- have an undetectable viral load at screening.
- Participants seropositive for hepatitis B virus (HBV), must have HBV viral load undetectable at screening.
- Participants seropositive for hepatitis C virus (HCV) must:
- received curative treatment; and
- have an undetectable HCV viral load at screening.
- Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use an effective method of contraception (barrier, hormonal, intrauterine device [IUD], surgical sterilization...
- Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study agents.
- The ability of the participant to understand and the willingness to sign a written informed consent document.
- Any investigational agents should be stopped at least 28 days prior to the first dose of [203Pb]VMT-Alpha-NET.
- Systemic therapy should be stopped at least 28 days prior to the first dose of [203Pb]VMT-Alpha-NET (participants with prior systemic therapies for their malignancy only, except participants with SCLC).
- Systemic therapy should be stopped at least 14 days prior to the first dose of [203Pb]VMT-Alpha-NET (participants with SCLC only).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to VMT-Alpha-NET.
- Positive Beta human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.
- QTc \> 450 ms on electrocardiogram (EKG) at screening. Note: Framingham correction for QTc will be used
- History of or detection at screening of active/untreated secondary malignancy except nonmelanoma skin cancer and carcinoma in situ of the uterine cervix.
- Uncontrolled intercurrent illness, factors, evaluated by medical history and physical exam which would potentially increase in the risk of the participant.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.