Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)

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Brief Title

Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)

Official Title

NOTCH 1 Inhibitor Brontictuzumab for Adenoid Cystic Carcinoma Bearing Two Activating NOTCH1 Mutations

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.
    


Study Type

Interventional


Primary Outcome

Number of Participants With Disease Progression


Condition

Adenoid Cystic Carcinoma

Intervention

Brontictuzumab

Study Arms / Comparison Groups

 Brontictuzumab
Description:  1.5 mg/Kg of Brontictuzumab single agent intravenously every three weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

1

Start Date

December 29, 2015

Completion Date

March 6, 2016

Primary Completion Date

March 6, 2016

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Renata Ferrarotto, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02662608

Organization ID

CIND15-0074


Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center


Study Sponsor

Renata Ferrarotto, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

May 2017