Mitotane

Generic Name: Mitotane

Brand Names: Lysodren

Drug Type: Small Molecule

Chemical Formula: C_₁₄H_₁₀Cl_₄

CAS Number: 53-19-0

Unique Ingredient Identifier: 78E4J5IB5J

Background: A derivative of the insecticide dichlorodiphenyldichloroethane that specifically inhibits cells of the adrenal cortex and their production of hormones. It is used to treat adrenocortical tumors and causes CNS damage, but no bone marrow depression.

Indication: For treatment of inoperable adrenocortical tumours; Cushing's syndrome

Associated Conditions: Cushing's Syndrome, Inoperable Adrenocortical carcinoma

Associated Therapies: -

Clinical Trials

A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma

Phase 2

Completed

Conditions: Adrenocortical Carcinoma

Interventions: Drug: Mitotane
Drug: Pembrolizumab

First Posted Date: 2022-12-02

Last Posted Date: 2024-10-23

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 3

Registration Number: NCT05634577

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma

Completed

Conditions: Adrenocortical Carcinoma

Interventions: Drug: Mitotane

First Posted Date: 2022-04-25

Last Posted Date: 2023-03-08

Lead Sponsor: King's College Hospital NHS Trust

Target Recruit Count: 35

Registration Number: NCT05344027

Locations: 🇬🇧
King's College Hospital NHS Foundation Trust, London, United Kingdom

Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence

Phase 3

Recruiting

Conditions: ENSAT Stage I Adrenal Cortex Carcinoma
ENSAT Stage II Adrenal Cortex Carcinoma
ENSAT Stage III Adrenal Cortex Carcinoma

Interventions: Drug: Mitotane
Drug: Cisplatin
Other: Quality-of-Life Assessment
Drug: Etoposide

First Posted Date: 2018-07-11

Last Posted Date: 2024-10-15

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 240

Registration Number: NCT03583710

Locations: 🇸🇪
Sahlgrenska University Hospital, Gothenburg, Sweden
🇸🇪
Karolinska University Hospital, Stockholm, Sweden
🇸🇪
Akademiska Sjukhuset, Uppsala, Sweden

and more 5 locations

A Safety and Feasibility Study of Mitotane in Prostate Cancer

Phase 1

Completed

Conditions: Prostate Cancer

Interventions: Drug: Mitotane

First Posted Date: 2014-02-07

Last Posted Date: 2015-12-17

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 1

Registration Number: NCT02057237

Locations: 🇨🇦
University Health Network, Toronto, Ontario, Canada

IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery

Phase 2

Terminated

Conditions: Recurrent Adrenocortical Carcinoma
Stage III Adrenocortical Carcinoma
Stage IV Adrenocortical Carcinoma

Interventions: Biological: IMC-A12
Drug: mitotane

First Posted Date: 2008-10-23

Last Posted Date: 2014-04-29

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT00778817

Locations: 🇺🇸
University of Michigan, Ann Arbor, Michigan, United States
🇺🇸
Memorial Medical Center, Springfield, Illinois, United States
🇺🇸
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States

and more 5 locations

Efficacy of Adjuvant Mitotane Treatment (ADIUVO)

Phase 3

Conditions: Adrenocortical Carcinoma

Interventions: Drug: MITOTANE

First Posted Date: 2008-10-22

Last Posted Date: 2017-05-08

Lead Sponsor: University of Turin, Italy

Target Recruit Count: 200

Registration Number: NCT00777244

Locations: 🇨🇦
Endocrinologie - Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Canada
🇮🇹
Azienda Ospedaliera San Luigi, Orbassano, Italy
🇮🇹
Policlinico Universitario A. Gemelli, Roma, Italy

and more 25 locations

Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor

Phase 3

Completed

Conditions: Stage III Adrenal Cortical Carcinoma AJCC v7
Stage I Adrenal Cortical Carcinoma AJCC v7
Stage II Adrenal Cortical Carcinoma AJCC v7
Stage IV Adrenal Cortical Carcinoma AJCC v7

Interventions: Procedure: Conventional Surgery
Drug: Cisplatin
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Biological: Filgrastim
Drug: Mitotane
Biological: Pegfilgrastim

First Posted Date: 2006-03-17

Last Posted Date: 2024-02-28

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 78

Registration Number: NCT00304070

Locations: 🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
🇨🇦
Hospital for Sick Children, Toronto, Ontario, Canada

and more 88 locations

Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)

Phase 3

Completed

Conditions: Carcinoma, Adrenal Cortical

Interventions: Drug: Streptozotocin
Drug: Etoposide
Drug: Mitotane
Drug: Doxorubicin
Drug: Cisplatin

First Posted Date: 2004-10-20

Last Posted Date: 2016-09-21

Lead Sponsor: Collaborative Group for Adrenocortical Carcinoma Treatment

Target Recruit Count: 304

Registration Number: NCT00094497

Locations: 🇺🇸
National Cancer Institute - Center for Cancer Research, Bethesda, Maryland, United States
🇺🇸
University of Michigan, Department of Internal Medicine, Ann Arbor, Michigan, United States
🇦🇺
Royal Adelaide Hospital, Adelaide, Australia

and more 29 locations

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