Study Stopped
The trial was permanently halted due to futility concerns.
IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery
Multi-Institutional Phase II Study of IMC-A12, a Recombinant Human IgG1 Monoclonal Antibody Directed at the Type I Insulin-Like Growth Factor Receptor IGF1R, in Adrenocortical Carcinoma: IMC-A12 With Mitotane vs Mitotane Alone
11 other identifiers
interventional
20
1 country
8
Brief Summary
This randomized phase II trial is studying mitotane and IMC-A12 to see how well they work compared with mitotane alone in treating patients with recurrent, metastatic, or primary adrenocortical cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as mitotane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as IMC-A12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether mitotane is more effective with or without monoclonal antibody IMC-A12 in treating adrenocortical cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2008
Longer than P75 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2008
CompletedFirst Posted
Study publicly available on registry
October 23, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedResults Posted
Study results publicly available
November 6, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedApril 29, 2014
December 1, 2013
3.4 years
October 22, 2008
August 30, 2013
March 28, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
Progression-free Survival Rate at 6 Weeks
Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by 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.
6 weeks
Progression-free Survival Rate at 12 Weeks
Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by 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.
12 weeks
Progression-free Survival Rate at 18 Weeks
Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by 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.
18 weeks
Secondary Outcomes (9)
Best Response Rates
Up to 6 months
Response at 6 Weeks
6 weeks
Response at 12 Weeks
12 weeks
Response at 18 Weeks
18 weeks
Response at 48 Weeks
48 weeks
- +4 more secondary outcomes
Study Arms (1)
Arm II (Mitotane + IMC-A12)
EXPERIMENTALPatients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed adrenocortical carcinoma
- Documented unresectable recurrent, unresectable advanced, or metastatic disease
- At least 1 lesion that can be accurately measured by RECIST criteria as ≥ 20 mm by conventional radiologic techniques or as ≥ 10 mm by spiral CT scan or MRI
- Patients with disease in an irradiated field as the only site of measurable disease allowed provided there has been a clear progression of the lesion
- No tumors potentially resectable by surgical excision alone
- No known or suspected leptomeningeal disease or brain metastases
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL (transfusion allowed)
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 60 mL/min
- AST or ALT ≤ 3 times ULN
- Total bilirubin ≤ 1.5 times ULN
- HbA1c \< 8 within the past 4 weeks
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of Southern California
Los Angeles, California, 90033-0804, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 60702, United States
Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
After the treatment of 20 subjects, a protocol defined interim analysis was completed for safety and futility. The trial was permanently halted based on futility concerns.
Results Point of Contact
- Title
- Walter M. Stadler, MD
- Organization
- The University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Hammer
University of Chicago Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2008
First Posted
October 23, 2008
Study Start
December 1, 2008
Primary Completion
May 1, 2012
Study Completion
March 1, 2014
Last Updated
April 29, 2014
Results First Posted
November 6, 2013
Record last verified: 2013-12