Study on 177Lu-PSMA Treatment for PSMA-Positive Adenoid Cystic Carcinoma

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06322576

Provider View

This clinical trial is testing a new treatment using 177Lu-PSMA for patients with adenoid cystic carcinoma (ACC) that has returned or spread and cannot be treated with surgery. The study will first assess the feasibility of the treatment before potentially moving to a second phase.

Patient Parameters

Program Overview

This study is exploring a new treatment for adenoid cystic carcinoma (ACC), a type of cancer affecting the salivary glands, using a radioactive drug called 177Lu-PSMA. The trial is for patients whose cancer has come back or spread and cannot be removed with surgery. Initially, 10 participants will undergo special imaging tests to see how the treatment is absorbed by the tumors. If successful, the study may proceed to a second phase where participants will receive the treatment and undergo regular check-ups, including blood tests and scans, over a period of about two years.

Description

Adenoid cystic carcinoma (ACC) is a rare type of cancer that usually affects the salivary glands but can also occur in other areas of the head and neck. It accounts for about 10% of all salivary gland tumors. Current treatments for ACC that has returned or spread include certain chemotherapy drugs, but these often have low success rates, and there are no effective second-line treatments. This study aims to test a new approach using 177Lu-PSMA, a radioactive drug that targets cancer cells, to see if it can improve outcomes for patients with ACC.

The trial will start with a small group of participants who will undergo imaging tests to measure how well the drug is absorbed by the tumors. If the results are promising, the study will move to a second phase where participants will receive the treatment and be monitored for side effects and effectiveness. The study will involve regular visits for blood tests, physical exams, and imaging scans, and participants will be asked to complete questionnaires about their health and quality of life. The goal is to find a more effective treatment option for patients with ACC.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of adenoid cystic carcinoma (ACC), either primary or metastatic.
  • Cancer has returned or spread and cannot be treated with surgery or radiotherapy.
  • At least one tumor shows positive results on a PSMA-PET scan.
  • Can have had any number of previous treatments.
  • At least 28 days since the last cancer treatment or 5 half-lives of the previous treatment, whichever is shorter.
  • Recovery from any previous treatment side effects to a mild level.
  • Aged 18 years or older.
  • General health status allowing for daily activities with some limitations.
  • For women of childbearing potential and men with partners of childbearing potential, agreement to use effective birth control during the study and for 6 months after the last dose of 177Lu-PSMA.
  • Ability to understand and willingness to sign a consent form.

Exclusion Criteria

  • Spinal cord compression or risk of spinal cord compression.
  • Suspected large lung or liver metastases.
  • Unable to lie flat or tolerate imaging tests.
  • Refusal to sign consent form.
  • Medical conditions that could make participation unsafe.

Additional criteria for potential second phase participants:

  • Adequate blood cell counts and organ function, including:

    • Platelet count over 100,000/mL
    • White blood cell count over 3,000/mL
    • Neutrophil count over 1,500/mL
    • Hemoglobin level of at least 10 g/dL
    • Kidney function with an estimated filtration rate over 50 mL/min
    • Liver enzymes and bilirubin within specified limits
    • Serum albumin over 30 g/L

  • Not participating in another study involving radiotherapy, surgery, or other cancer treatments.

  • Not receiving any other investigational drugs.

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