Surgery Clinical Trial
Official title:
Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery
Verified date | February 2022 |
Source | Alume Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head & neck surgery.
Status | Completed |
Enrollment | 41 |
Est. completion date | February 15, 2022 |
Est. primary completion date | June 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. A neoplasm located in the head and neck. 2. Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck dissection. 3. Can understand and is willing to sign a written informed consent document. 4. =18 years of age. 5. Life expectancy of at least 6 months. 6. Normal liver and kidney functions. 7. If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence. The subject, if male, must use a medically acceptable form of contraception (e.g. condom) or abstinence. 8. Plans to undergo head and neck surgery. Exclusion Criteria: 1. Prior radiation or chemotherapy for any prior head and neck neoplasm. 2. Open surgery in the ipsilateral head and neck within 1 year. 3. Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year. 4. Current evidence of renal disease. 5. Pregnant or breastfeeding. 6. Unresolved acute toxicity from prior anti-cancer therapy. 7. History of fluorescein allergy. 8. Any other criteria deemed by the Principal Investigator that may prevent the patient from successfully completing the trial. |
Country | Name | City | State |
---|---|---|---|
United States | Harvard-Mass Eye & Ear | Boston | Massachusetts |
United States | University of California San Diego | San Diego | California |
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Alume Biosciences, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of ALM-488 related Adverse Events | Incidence of ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | 28 (+5) days | |
Secondary | Concentration of ALM-488 in blood | Concentration of ALM-488 in blood at varying times following ALM-488 administration. | 28 (+5) days | |
Secondary | Dose determination | To determine the recommended dose of ALM-488. | 9 months | |
Secondary | Timing determination | To evaluate the effect of timing of administration of ALM-488. | 3 months |
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