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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR MITOTANE

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Clinical Trials for Mitotane

Trial ID Title Status Sponsor Phase Summary
NCT00001339 A Study of Combination Chemotherapy and Surgical Resection in the Treatment of Adrenocortical Carcinoma: Continuous Infusion Doxorubicin, Vincristine and Etoposide With Daily Mitotane Before and After Surgical Resection Completed National Cancer Institute (NCI) Phase 2 Patients who have no response to preoperative chemotherapy and no residual disease following surgery on Regimen A are treated on Regimen B postoperatively. The following acronyms are used: DDD Mitotane, NSC-38721 DOX Doxorubicin, NSC-123127 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 Regimen A: 4-Drug Combination Chemotherapy followed by Surgery followed by 4-Drug Combination Chemotherapy. DDD/DOX/VCR/VP-16; followed by surgical debulking; followed by DDD/DOX/VCR/VP-16. Regimen B: Single-Agent Chemotherapy. DDD.
NCT00002921 S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery Terminated National Cancer Institute (NCI) Phase 2 RATIONALE: Some tumors need growth factors produced by the body to keep growing. Suramin may interfere with the growth factor and stop the tumor from growing. PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with stage III or stage IV adrenocortical cancer.
NCT00002921 S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery Terminated Southwest Oncology Group Phase 2 RATIONALE: Some tumors need growth factors produced by the body to keep growing. Suramin may interfere with the growth factor and stop the tumor from growing. PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with stage III or stage IV adrenocortical cancer.
NCT00071058 Surgery Plus Chemotherapy (Doxorubicin, Vincristine and Etoposide), Mitotane, and Tariquidar to Treat Adrenocortical Cancer Completed National Cancer Institute (NCI) Phase 2 This study will examine the safety and effectiveness of treating adrenocortical cancer with combination chemotherapy using doxorubicin, vincristine, and etoposide in addition to the drugs mitotane and tariquidar and, when possible, surgery. Adrenocortical cancer cells have a large amount of a protein called P-glycoprotein that "pumps" anti-cancer drugs out of the cells, decreasing their effectiveness. Continuous infusions of doxorubicin, vincristine, and etoposide may improve chemotherapy results by blocking the P-glycoprotein pump, as may use of tariquidar, an experimental drug that is known to block the P-glycoprotein pump. Patients 18 years of age and older with adrenocortical cancer that has recurred, spread, or cannot be treated surgically may be eligible for this study. Candidates will be screened with a medical history and physical examination; review of pathology slides; blood tests; electrocardiogram (EKG); imaging tests, including computed tomography (CT) of the chest, abdomen and pelvis; chest x-ray; and possibly a bone scan or other imaging tests needed to evaluate the cancer, urine studies, and an echocardiogram. Also, a biopsy (removal of a small sample of tumor tissue) may be required if a specimen is not available to confirm the cancer. Participants will undergo the following tests and procedures: - Tumor biopsy. Before starting chemotherapy, a small piece of tumor is removed to study the P-glycoprotein pump and to determine the tumor genetics. - Blood draw. Blood is drawn before treatment begins to establish baseline levels for future blood tests. - Central venous catheter placement. A specially trained physician places a plastic tube into a major vein in the chest. The tube is used to give the study drugs and other medications and to withdraw blood samples. It can stay in the body for months or be removed after each treatment is completed. The tube placement is done under a local anesthetic in the radiology department or operating room. - Chemotherapy. Treatment cycles are 21 days. Doxorubicin, vincristine, and etoposide are given through the central venous catheter by an infusion pump continuously over 96 hours starting day 1 of each cycle. The dose of these drugs may be increased or decreased from cycle to cycle, based on side effects. Mitotane is given in pill form starting day 1 of cycle 1 and is taken every day throughout the entire study. The mitotane dose is gradually increased as long as the side effects are tolerable. Tariquidar is given through the central venous catheter as a 30-minute infusion on days 1 and 3 of every cycle. The tariquidar dose remains the same throughout the study. Treatment will continue for two cycles after all the cancer is gone, or until surgery is done to remove some or all of the remaining cancer, or, if surgery is not an option, until the cancer has grown to where it is defined as progressive disease. - Nuclear scans. A nuclear scan is done before treatment begins and again on day 1 or day 3 of the first treatment cycle after administration of tariquidar to evaluate the P glycoprotein response to treatment. - Computed tomography (CT) scans. These scans are done every two treatment cycles to follow disease progress. - Surgery. Surgery to remove areas of cancer may be considered at any point during the study (including before beginning treatment), if it is deemed beneficial. Treatment with the study drugs will begin or resume after surgery. The length of treatment will depend on the response to treatment before the surgery and on whether there is any cancer remaining after the surgery.
NCT00094497 Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT) Completed German Federal Ministry of Education and Research Phase 3 The purpose of this study is to determine whether treatment with etoposide, doxorubicin, cisplatin and mitotane (EDP/M) prolongs survival as compared to streptozotocin and mitotane (Sz/M) in patients with advanced adrenocortical carcinoma (ACC) whose disease is not amenable to complete surgical resection.
NCT00094497 Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT) Completed National Cancer Institute (NCI) Phase 3 The purpose of this study is to determine whether treatment with etoposide, doxorubicin, cisplatin and mitotane (EDP/M) prolongs survival as compared to streptozotocin and mitotane (Sz/M) in patients with advanced adrenocortical carcinoma (ACC) whose disease is not amenable to complete surgical resection.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Mitotane

Condition Name

Condition Name for Mitotane
Intervention Trials
Adrenocortical Carcinoma 8
Adrenal Cortex Neoplasms 2
Peritoneal Carcinomatosis 2
Stage IV Adrenocortical Carcinoma 2
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Condition MeSH

Condition MeSH for Mitotane
Intervention Trials
Adrenocortical Carcinoma 16
Carcinoma 14
Adrenal Cortex Neoplasms 4
Recurrence 1
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Clinical Trial Locations for Mitotane

Trials by Country

Trials by Country for Mitotane
Location Trials
United States 81
Canada 7
Italy 6
Brazil 3
Germany 3
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Trials by US State

Trials by US State for Mitotane
Location Trials
Maryland 7
Michigan 5
Texas 4
California 3
Ohio 3
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Clinical Trial Progress for Mitotane

Clinical Trial Phase

Clinical Trial Phase for Mitotane
Clinical Trial Phase Trials
Phase 4 1
Phase 3 5
Phase 2 11
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Clinical Trial Status

Clinical Trial Status for Mitotane
Clinical Trial Phase Trials
Completed 7
Not yet recruiting 3
Recruiting 3
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Clinical Trial Sponsors for Mitotane

Sponsor Name

Sponsor Name for Mitotane
Sponsor Trials
National Cancer Institute (NCI) 8
Azienda Ospedaliera Spedali Civili di Brescia 3
M.D. Anderson Cancer Center 2
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Sponsor Type

Sponsor Type for Mitotane
Sponsor Trials
Other 25
NIH 8
Industry 2
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