AL101 Before Surgery for the Treatment of Notch Activated Adenoid Cystic Cancer
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|ClinicalTrials.gov Identifier: NCT04973683|
Recruitment Status : Not yet recruiting
First Posted : July 22, 2021
Last Update Posted : July 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Adenoid Cystic Carcinoma Metastatic Adenoid Cystic Carcinoma||Drug: AL101 Procedure: Therapeutic Conventional Surgery||Phase 1|
I. To evaluate the safety and feasibility of AL101 administered weekly for 6 to 8 weeks in the preoperative setting using National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
II. To determine the differences between NICD1 levels by immunohistochemistry (IHC) in the post-treatment surgical specimens as compared to baseline in patients treated with AL101.
I. To evaluate the objective response rate (ORR) to AL101 by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 6 to 8 weeks.
II. To assess percentage of patients undergoing the initially proposed surgery. III. To assess percentage of viable tumor cells in the surgical specimen (pathologic response) following AL101 treatment.
I. To evaluate pre- and post- treatment tumor and blood biomarkers and correlate with clinical and pathologic response and toxicity.
Patients receive AL101 intravenously (IV) over 60 minutes once weekly (QW) for 6-8 weeks in the absence of disease progression or unacceptable toxicity. Within 24-72 hours after the last infusion of AL101, patients undergo surgery per standard of care. Patients may continue AL101 after surgery at the discretion of the study doctor.
After completion of study, patients are followed up within 6 weeks after surgery or within 30 days after last dose of AL101, and then every 6 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||AL101 Prior to Standard-of-Care Surgery in Patients With Notch Activated Adenoid Cystic Carcinoma (ACC)|
|Estimated Study Start Date :||November 30, 2021|
|Estimated Primary Completion Date :||April 19, 2023|
|Estimated Study Completion Date :||April 19, 2023|
Experimental: Treatment (AL101)
Patients receive AL101 IV over 60 minutes QW for 6-8 weeks in the absence of disease progression or unacceptable toxicity. Within 24-72 hours after the last infusion of AL101, patients undergo surgery per standard of care. Patients may continue AL101 after surgery at the discretion of the study doctor.
Procedure: Therapeutic Conventional Surgery
Undergo standard of care surgery
- Incidence of adverse events [ Time Frame: Up to 2 years ]Adverse events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Frequency tables will summarize toxicity data for all patients. Logistic regression may be utilized to assess the effect of patient prognostic factors on the response and toxicity.
- Changes in NICD1 levels [ Time Frame: Baseline and after surgery ]Evaluated by immunohistochemistry in the post-treatment surgical specimen (at 6 to 8 weeks) as compared to baseline (pre-treatment) in patients treated with AL101
- Overall response rate [ Time Frame: At 6-8 weeks ]Evaluated per Response Evaluation Criteria in Solid Tumors. Logistic regression may be utilized to assess the effect of patient prognostic factors on the response and toxicity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04973683
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Contact: Renata Ferrarotto 713-792-6363 email@example.com|
|Principal Investigator: Renata Ferrarotto|
|Principal Investigator:||Renata Ferrarotto||M.D. Anderson Cancer Center|