IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery
Stopped early · Phase 2
Conditions studied: Recurrent Adrenocortical Carcinoma, Stage III Adrenocortical Carcinoma, Stage IV Adrenocortical Carcinoma
In brief
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.
Key facts
- Study ID
- NCT00778817
- Run by
- National Cancer Institute (NCI)
- People needed
- 20
- Starts
- 2008-12-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2014-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- Able to take oral medications
- No poor gastrointestinal absorption
- Patients with diabetes mellitus are eligible provided they meet all of the following criteria:
- Blood glucose is normal (random glucose ≤ 150 mg/dL)
- HgbA1c ≤ 8 within the past 4 weeks
- On a stable dietary or therapeutic regimen for the past 2 months
- No active uncontrolled infection
Where it is running
- University of Southern California — Los Angeles, California, United States
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
- Decatur Memorial Hospital — Decatur, Illinois, United States
- Central Illinois Hematology Oncology Center — Springfield, Illinois, United States
- Memorial Medical Center — Springfield, Illinois, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States
- Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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