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Lysodren (Mitotane) - Summary



LYSODREN (mitotane tablets, USP) should be administered under the supervision of a qualified physician experienced in the uses of cancer chemotherapeutic agents. LYSODREN should be temporarily discontinued immediately following shock or severe trauma since adrenal suppression is its prime action. Exogenous steroids should be administered in such circumstances, since the depressed adrenal may not immediately start to secrete steroids.



LYSODREN® (mitotane tablets, USP) is an oral chemotherapeutic agent.

LYSODREN is indicated in the treatment of inoperable adrenal cortical carcinoma of both functional and nonfunctional types.

See all Lysodren indications & dosage >>


Published Studies Related to Lysodren (Mitotane)

Effect of mitotane on pituitary corticotrophs in clinically normal dogs. [2006.08]
OBJECTIVE: To evaluate the effects of mitotane administration on the function and morphology of pituitary corticotrophs in clinically normal dogs...

[Mitotane as possible cause of acute intermittent porphyria]. [2011.09.12]
A 54 year-old woman with acute intermittent porphyria (AIP) developed an attack of porphyria after 156 days of treatment with mitotane following a non-radical adrenalectomy for adrenocortical carcinoma. Mitotane therapy was discontinued but the attack of porphyria persisted for more than four months and included episodes with severe metabolic and neurologic toxicities.

Plasma concentrations of o,p'DDD, o,p'DDA, and o,p'DDE as predictors of tumor response to mitotane in adrenocortical carcinoma: results of a retrospective ENS@T multicenter study. [2011.06]
CONCLUSIONS: Our data confirm the value of o,p'DDD plasma monitoring as well as targeting the 14 mg/liter cutoff level in the therapeutic management of ACC patients. Furthermore, our results suggest additional benefit of higher levels of o,p'DDD and combined measurement of o,p'DDD and o,p'DDA.

High (18)F-FDG uptake by the remaining adrenal gland four months after surgery and initiation of mitotane treatment in two patients with adrenocortical carcinoma. [2011.05]
Two men, one 42 and the other 35 years old were both subjected to adrenalectomy for adrenocortical carcinoma (ACC). Adjuvant treatment with mitotane [o,p-dichloro-diphenyl-dichloroethane, (o,p-DDD)], was initiated following surgery... In conclusion, an abnormal high (18)F-FDG uptake was observed in the contralateral adrenal gland in both our adrenalectomized ACC patients, 4 months after starting mitotane treatment, probably related to mitotane's effect on steroid metabolism, not yet fully understood.

Mitotane has a strong and a durable inducing effect on CYP3A4 activity. [2011.04]
OBJECTIVE: The effects of mitotane on the pharmacokinetics (PK) of co-administered drugs are mostly unknown. The aim of the present study was to describe the effects of mitotane on the PK of the phenotypic probe midazolam and of the tyrosine kinase inhibitor sunitinib... CONCLUSION: Mitotane has a strong and long-lasting inducing effect on CYP3A4 activity, which will result in clinically relevant interactions with multiple drugs since many drugs are metabolized by this enzyme.

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Clinical Trials Related to Lysodren (Mitotane)

Mitotane With or Without IMC-A12 in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery [Recruiting]
RATIONALE: 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.

PURPOSE: 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.

International Study: Comparison of Two Treatments for Adrenocortical Cancer [Recruiting]

- There is no medical consensus about the best treatment for advanced adrenocortical

cancer (ACC) that cannot successfully be treated with surgery alone.

- In 2003, the International Consensus Conference on Adrenal Cancer recommended two

chemotherapy regimens - etoposide, doxorubicin, cisplatin plus mitotane and

streptozotocin plus mitotane- as the best choices until better data could be obtained. All the drugs in the two options have been shown effective against advanced ACC, but they have different side effects.


- To determine which of the chemotherapy regimens described above is best to start with

in patients with ACC that cannot be surgically removed.

- To determine if there is a way to identify which patients will respond to a certain



- Patients 18 years of age and older from the USA, Scandinavia, Germany, Italy, France, The

Netherlands, Belgium, the UK, Canada and Australia who have adrenocortical cancer that cannot be cured with surgery alone.


- Chemotherapy: Patients are randomly assigned to start with one of the two study

regimens. Patients whose tumor continues to grow during treatment are offered the alternative therapy. All patients receive daily tablets of mitotane. In addition, they have one of the following two regimens:

- Streptozotocin every 3 weeks for up to six cycles. The first cycle is given on days 1,

2, 3, 4 and 5 and subsequent cycles are given on day 1 only.

- Cisplatin plus etoposide plus doxorubicin every 4 weeks for up to six cycles.

Doxorubicin is given on day 1, etoposide is given on days 2, 3 and 4 and cisplatin is given on days 3 and 4.

- CT scans of the chest, abdomen and pelvis approximately once every 8 weeks.

- Physical examination, routine blood tests and a check of side effects at the start of

each treatment cycle.

- Blood test to determine if the hormones produced by some adrenocortical cancers have

any effect on the immune system.

- Analysis of genetic markers in blood and tumor tissue for comparison with tumor growth

and patient survival to determine if this can help identify which patients will respond to a certain therapy.

- Optional procedures:

- Storage of blood and tissue samples for future research.

- Completion of quality-of-life questionnaires every 2 months.

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]
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.

Efficacy of Adjuvant Mitotane Treatment (ADIUVO) [Recruiting]
Study Rationale Adrenocortical carcinoma (ACC) is a very rare disease with a high risk of relapse after radical surgery. The efficacy of adjuvant mitotane treatment is suggested by a retrospective multicenter international study showing that postoperative mitotane treatment was associated with a significant reduction of the risk of relapse and death. However, these promising results need confirmation in a randomized prospective study. Caution should be adopted particularly in patients with low risk of disease relapse, in whom the benefit of therapy should be weighted against the side effects. Even if an adjuvant treatment seems justified in patients at high risk of relapse, a randomised prospective study is needed to assess whether such a treatment is efficacious in patients at low-intermediate risk. The purpose of the present study is to determine whether adjuvant mitotane treatment is effective in prolonging the disease free survival in patients with adrenocortical carcinoma at low-intermediate risk of progression who underwent radical resection

A Safety and Feasibility Study of Mitotane in Prostate Cancer [Recruiting]
1. The primary objective of this study is to assess the feasibility of treating patients with metastatic castration resistant prostate cancer with mitotane. Secondary objectives are to assess safety and tolerability as well as response rate of therapy 2. To assess the toxicity of Mitotane in men with HRPC 3. To assess the relationship between baseline serum adrenal androgens and their response to Mitotane

more trials >>

Reports of Suspected Lysodren (Mitotane) Side Effects

Altered State of Consciousness (5)Adrenal Insufficiency (4)Cholestasis (3)Coma (3)Somnolence (3)OFF Label USE (3)Gamma-Glutamyltransferase Increased (3)Cytolytic Hepatitis (3)Aggression (3)Neoplasm Progression (2)more >>

Page last updated: 2011-12-09

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