Adenoid Cystic Carcinoma
Conditions
Keywords
Brontictuzumab
Brief summary
The goal of this study is to start treatment with the NOTCH1 inhibitor brontictuzumab in an attempt to control tumors and prolong survival. The therapy involves participant being given the drug brontictuzumab to treat adenoid cystic carcinoma (ACC) with NOTCH 1 mutations. This is considered an investigational treatment.
Detailed description
Treatment: Participant will receive brontictuzumab by vein over 30 minutes one time every 3 weeks. Clinic Visits: On Day 1 of Cycle 1 and then every 3 weeks from then on: * Participant will have a physical exam * Blood (about 3 teaspoons) will be drawn for routine tests. Every 6 weeks, participant will have an MRI and CT scan to check the status of the disease. Length of Treatment: Participant may continue taking brontictuzumab for as long as the doctor thinks it is in their best interest. Participant will no longer be able to take the drug if the disease gets worse, they develop another illness that prevents receiving more treatment, or if intolerable side effects occur. Brontictuzumab is not FDA approved or commercially available. It is currently being used for research purposes only.
Interventions
DRUGBrontictuzumab
1.5 mg/Kg intravenously every three weeks.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 2. Organ and marrow function as follows: absolute neutrophil count (ANC) ≥1000/mm3, platelets ≥50,000/dL, hemoglobin ≥8 g/dL, bilirubin ≤ 1.5 times the upper limit of normal, serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal. 3. Central Nervous System (CNS) metastases allowed if subject does not require steroids, brain metastases are clinically stable without symptomatic progression 4. Capability to understand and comply with the protocol and signed informed consent document.
Exclusion criteria
1. Major medical conditions that might affect study participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease) 2. Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Disease Progression | 6 weeks | Tumor response for measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) to establish disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
Countries
United States
Participant flow
Recruitment details
Study recruitment was limited to single participant compassionate use in December 2015.
Participants by arm
| Arm | Count |
|---|---|
| Brontictuzumab Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Brontictuzumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Number of Participants With Disease Progression
Tumor response for measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) to establish disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brontictuzumab | Number of Participants With Disease Progression | 1 Participants |