240 Participants Needed

Mitotane +/- Cisplatin and Etoposide for Adrenal Cancer

Recruiting at 8 trial locations
MH
Overseen ByMouhammed Habra
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: M.D. Anderson Cancer Center
Must be taking: Mitotane
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since the trial involves chemotherapy drugs, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators or your doctor for specific guidance.

What data supports the idea that Mitotane +/- Cisplatin and Etoposide for Adrenal Cancer is an effective drug?

The available research does not provide specific data on the effectiveness of Mitotane +/- Cisplatin and Etoposide for Adrenal Cancer. The studies mentioned focus on other conditions, such as non-Hodgkin lymphoma, ovarian cancer, and Ewing sarcoma, using similar drugs. For example, one study showed a 55% response rate in non-Hodgkin lymphoma patients using a combination that included etoposide. Another study reported responses in ovarian cancer patients who had not responded to previous treatments. However, these results cannot be directly applied to adrenal cancer without specific research on that condition.12345

What safety data is available for Mitotane, Cisplatin, and Etoposide treatment?

The safety data for the combination of Cisplatin and Etoposide, sometimes with Mitotane, shows significant toxicities. In a study with advanced non-small-cell lung cancer patients, high-dose Cisplatin and Etoposide caused major myelosuppression, with 26% developing neutropenic fever, and one patient died due to toxicity. Nonhematologic toxicities included azotemia, peripheral neuropathy, nausea, vomiting, and hearing loss, which were transient and modest. Another study in Hodgkin's disease patients reported significant leukopenia, thrombocytopenia, and severe nausea and vomiting with the Cisplatin and Etoposide combination. These findings suggest that while the combination can be active, it is associated with considerable toxicity.34678

Is the drug Mitotane a promising treatment for adrenal cancer?

The information provided does not directly address the effectiveness of Mitotane for adrenal cancer. The articles focus on other drugs and treatments for different types of cancer. Therefore, based on the given information, we cannot determine if Mitotane is a promising treatment for adrenal cancer.2891011

What is the purpose of this trial?

This phase III trial studies how well mitotane alone works compared to mitotane with cisplatin and etoposide when given after surgery in treating patients with adrenocortical cancer that has a high risk of coming back (recurrence). Cortisol can cause the growth of adrenocortical tumor cells. Antihormone therapy, such as mitotane, may lessen the amount of cortisol made by the body. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether mitotane alone or mitotane with cisplatin and etoposide after surgery works better in treating patients with adrenocortical carcinoma.

Research Team

MA

Mouhammed A. Habra

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with Stage I-III adrenocortical cancer who've had surgery to remove the tumor. They should be at high risk of the cancer returning, have a good performance status (able to carry out daily activities), and no recent other cancers or severe health issues. Pregnant or breastfeeding individuals can't join, nor those with kidney failure, heart failure, liver problems, bone marrow suppression, neuropathy, or prior ACC treatments.

Inclusion Criteria

I had adrenal cancer surgery recently and my cancer is at a high risk of coming back.
Be able to comply with the protocol procedures
Provide written informed consent
See 3 more

Exclusion Criteria

My platelet count is below 100,000/mm^3.
There is a strong chance that the cancer has spread to other parts of the body based on imaging tests.
Pregnancy or breast feeding
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mitotane daily for 21-day cycles, with or without cisplatin and etoposide for up to 4 cycles

Up to 2 years
Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 6 months

Treatment Details

Interventions

  • Cisplatin
  • Etoposide
  • Mitotane
Trial Overview The study compares two approaches after surgery: one group receives only mitotane (a drug that reduces cortisol production by the body) while another group gets mitotane combined with chemotherapy drugs cisplatin and etoposide. The goal is to see which method is more effective in preventing cancer recurrence.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm B (mitotane, etoposide, cisplatin)Experimental Treatment4 Interventions
Patients receive mitotane as in Arm A. Patients also receive cisplatin IV over 2 hours on day 1 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (mitotane)Experimental Treatment2 Interventions
Patients receive mitotane PO daily on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

Mitotane is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Lysodren for:
  • Adrenocortical carcinoma
🇪🇺
Approved in European Union as Lysodren for:
  • Adrenocortical carcinoma
  • Cushing's syndrome

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Assistance Publique - Hôpitaux de Paris

Collaborator

Trials
3,369
Recruited
57,400,000+

University Hospital Wurzburg

Collaborator

University Hospital Munich

Collaborator

Trials
20
Recruited
13,800+

Skanes Universitetssjukhus

Collaborator

Findings from Research

In a study of 29 patients with relapsing or refractory high-grade malignant non-Hodgkin lymphoma (NHL), the ENAP chemotherapy regimen showed a promising overall response rate of 55%.
When ENAP was used as a first-line treatment in 45 previously untreated NHL patients, it resulted in a complete remission rate of 27% and a partial remission rate of 73% after just one course, indicating its effectiveness as both a first-line and salvage treatment.
Mitoxantrone, etoposide, cytarabine and prednisone as salvage therapy for refractory non-Hodgkin lymphoma (NHL) and alternated with CHOP in previously untreated patients with NHL.Merk, K., Ideström, K., Johansson, B., et al.[2019]
In a phase II trial involving 31 patients with refractory ovarian carcinoma, intraperitoneal mitoxantrone showed efficacy, particularly in patients with small tumors (≤1 cm), where 33% had documented responses, including some who previously failed other treatments.
Despite its effectiveness, the treatment caused significant local toxicity, with 74% of patients requiring pain relief and several experiencing severe complications like bowel obstruction, leading to the conclusion that this regimen is not suitable for standard clinical practice without further modifications to reduce toxicity.
Phase II trial of intraperitoneal mitoxantrone in the management of refractory ovarian cancer.Markman, M., George, M., Hakes, T., et al.[2017]
In a study of 58 patients with relapsing/refractory Ewing sarcoma, low-dose oral etoposide (VP-16) demonstrated efficacy, with 11 out of 46 evaluable patients showing a response, including one complete remission and nine partial remissions, lasting an average of 8 months.
The treatment was associated with manageable toxicity, with 15% of cycles showing severe hematologic toxicity, and a noted risk of secondary leukemia, consistent with existing literature, suggesting that low-dose VP-16 could be a viable option in palliative care.
Oral etoposide in relapsed or refractory Ewing sarcoma: a monoinstitutional experience in children and adolescents.Podda, MG., Luksch, R., Puma, N., et al.[2017]

References

Mitoxantrone, etoposide, cytarabine and prednisone as salvage therapy for refractory non-Hodgkin lymphoma (NHL) and alternated with CHOP in previously untreated patients with NHL. [2019]
Phase II trial of intraperitoneal mitoxantrone in the management of refractory ovarian cancer. [2017]
Oral etoposide in relapsed or refractory Ewing sarcoma: a monoinstitutional experience in children and adolescents. [2017]
Etoposide and carbo-or cisplatin combination therapy in refractory or relapsed Ewing sarcoma: a large retrospective study. [2022]
Treatment for recurrent ovarian cancer. A report of 2 cases. [2014]
Phase II study of combination therapy with high-dose cisplatin, etoposide, and mitomycin in patients with advanced non-small-cell lung cancer. [2019]
Targeting the DNA repair pathway in Ewing sarcoma. [2022]
Phase II trial of etoposide and cis-diaminodichloro-platinum in patients with refractory and relapsed Hodgkin's disease: Cancer and Leukemia Group B (CALGB) Study 8353. [2019]
Phase II study of intraperitoneal cisplatin plus systemic etoposide as second-line treatment in patients with small volume residual ovarian cancer. [2019]
First-line cisplatin plus etoposide in high-grade metastatic neuroendocrine tumors of colon and rectum (MCRC NET): review of 8 cases. [2016]
The role of mitozantrone in the treatment of acute leukaemia. [2018]
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