Clinical trials on Adrenocortical Carcinoma

Adrenocortical carcinoma (ACC) is a rare and aggressive cancer originating in the cortex (outer layer) of the adrenal gland, where steroids hormones are produced. It can occur at any age but has a higher incidence in children and middle-aged adults. Complications of Adrenocortical Carcinoma can include:
  • Hormone Imbalances: Since ACC can produce hormones, it may lead to conditions such as Cushing’s syndrome or Conn’s syndrome, causing symptoms like high blood pressure, weight gain, and muscle weakness.
  • Metastasis: ACC may spread to other organs, affecting their function.
  • Local Mass Effect: A growing tumor can cause pain and pressure effects on adjacent structures in the abdomen.
  • Treatment Side Effects: Therapies for ACC, such as surgery and medications, can have complications, including infections, bleeding, or hormonal deficiencies.
Therapies for Adrenocortical Carcinoma include:
  • Surgery: The primary treatment is to surgically remove the tumor when localized.
  • Mitotane: A drug used specifically for treating ACC, aiming to reduce cortisol production and slow tumor growth.
  • Chemotherapy: Agents like etoposide, doxorubicin, and cisplatin are used, especially in advanced stages or post-surgery, to manage metastatic disease.
  • Radiation Therapy: May be utilized for local control or when the surgical option is not viable.
The prognosis for individuals with Adrenocortical Carcinoma varies widely and depends on several factors, including the stage at diagnosis, the tumor’s size, and whether it has spread. If detected early and localized, surgical removal can significantly improve outcomes. However, ACC is known for its potential for recurrence and metastasis, which may necessitate ongoing treatment. The prognosis is more guarded when the cancer is diagnosed at an advanced stage. Continuous follow-up with an oncology specialist is crucial for managing the disease and adjusting treatment strategies as necessary.
  • CT-EU-00112035

    Augmentation of standard chemotherapy with progesterone in adrenocortical cancer

    This is a phase II study aimed at patients with advanced adrenocortical carcinoma (ACC). The main aim of the study is to assess the effectiveness of adding progesterone to a standard chemotherapy regimen. This standard treatment includes a combination of drugs known as etoposide, doxorubicin, cisplatin and mitotane (EDP-M). Scientists believe that adding progesterone in the form of megestrol acetate may improve the effectiveness of the treatment against cancer.

    The test is for patients with advanced or metastatic ACC, which means the cancer has spread beyond its original location. Participants will be divided into two groups. One group will receive a standard treatment of EDP-M plus megestrol acetate, while the other group will receive a treatment of EDP-M plus a placebo. The main aspect researchers will look at is the objective response rate (ORR), which compares how well the cancer responds to treatment in both groups, based on specific criteria known as RECIST.

    • MITOTANE
    • Megestrol Acetate
    • Doxorubicin
    • Cisplatin
    • Etoposide
  • Analysis of dostarlimab as a first-line drug in the treatment of advanced non-colorectal cancers

    This clinical trial is focused on evaluating the effectiveness of an immunotherapy called dostarlimab for patients with certain types of advanced cancers that are not suitable for surgery. These cancers include pancreatic adenocarcinoma, carcinoma of the ampulla of Vater, adrenocortical carcinoma, high-grade neuroendocrine carcinoma, soft tissue sarcoma, and cancers of the small bowel, duodenum, and stomach. The study is specifically for those cancers that have a condition known as deficient mismatch repair (dMMR) or microsatellite instability (MSI), which are factors that can affect how a cancer responds to treatment.

    In this study, patients will be divided into two groups. One group will receive dostarlimab as a first-line treatment, which means it’s the first treatment given for their cancer. Dostarlimab is given through an IV (intravenously) and works by helping the immune system fight cancer. The other group will receive standard chemotherapy treatments, which are drugs used to kill cancer cells directly.

    An important aspect of this trial is that if patients in the chemotherapy group do not respond well to treatment and their cancer progresses, they may have the option to switch to the dostarlimab treatment, following a waiting period after their last dose of chemotherapy.

    The main goal of the study is to see if patients treated with dostarlimab live longer without their cancer getting worse compared to those receiving chemotherapy. This is known as progression-free survival.

    Before joining the study, patients will go through a screening process to confirm their eligibility, including tests to confirm their cancer has the dMMR/MSI condition. The trial will also involve regular check-ups to monitor how the cancer responds to the treatment and to check for any side effects.

    This study is an opportunity for patients with these specific types of advanced cancers to receive a new type of immunotherapy that could potentially offer better outcomes than standard chemotherapy.

    • Dostarlimab
  • Exploring Abiraterone Acetate for Cushing’s syndrome in adrenocortical carcinoma patients

    This clinical trial is focused on exploring the effectiveness of a medication called Abiraterone Acetate (Zytiga) in treating patients with Adrenocortical Carcinoma (ACC) who are also experiencing Cushing’s Syndrome. ACC is a very rare type of cancer that can affect the adrenal glands, and about half of the adults with this condition have tumors that produce excess hormones, leading to Cushing’s Syndrome. This syndrome is characterized by an overproduction of cortisol, a hormone, which can cause various health issues and negatively impact the treatment outcomes for patients with ACC.

    The study is designed to see if Abiraterone Acetate can help control the levels of cortisol in the body. This medication works by blocking certain enzymes (17α hydroxylase/C17, 20-lyase) involved in the production of cortisol and androgen hormones. It’s already used in treating prostate cancer but hasn’t been tested for Cushing’s Syndrome before.

    There are two groups of patients in this study:

    1. Those with advanced or metastatic ACC who haven’t been able to control their Cushing’s Syndrome with the standard treatment, Mitotane, and possibly chemotherapy. These patients will receive Abiraterone Acetate alone, stopping Mitotane and chemotherapy, and will continue with this treatment until their condition progresses or their Cushing’s Syndrome is under control.

    2. Patients who are newly diagnosed with ACC and Cushing’s Syndrome and cannot undergo surgery. Initially, they will be treated with Abiraterone Acetate alone for 4 weeks, followed by a combination of Abiraterone Acetate and Mitotane, with or without chemotherapy, for 3 months.

    The main goal of the study is to see if Abiraterone Acetate can normalize the levels of a hormone called urinary free cortisol (UFC) within a month of starting treatment. UFC levels are a way to measure the amount of cortisol in the body. Safety and the management of any side effects are important aspects of this study. The medication will be taken orally, and if any adverse effects occur, dose adjustments may be made.

    • Abiraterone Acetate
  • Comparison of adjuvant therapy for high-risk postoperative adrenocortical carcinoma

    The ADIUVO-2 Trial is a phase III clinical study designed to explore the best treatment approach for patients with Stage I-III Adrenocortical Cancer that has a high risk of returning after surgery. This trial is comparing two different treatment methods to see which one is more effective in preventing the cancer from coming back.

    One group of patients will receive a medication called mitotane by itself, which is known to reduce the amount of cortisol, a substance that can promote the growth of adrenocortical tumor cells. The other group will receive mitotane along with two chemotherapy drugs, cisplatin and etoposide, which work in various ways to stop tumor cells from growing or spreading.

    The main goal of this study is to see which treatment option better prevents the cancer from returning. This is measured by the time patients remain free from cancer recurrence. Additionally, the study will look at the overall survival of patients, how different factors like the level of mitotane in the blood, the stage of the disease, and how well the surgery went might influence the outcomes.

    The trial also aims to understand the impact of starting the treatment early (1-6 weeks after surgery) versus later (more than 6 weeks after surgery) on patient outcomes. Moreover, it will monitor any serious side effects and assess the quality of life of participants throughout the study using a specific questionnaire.

    For those interested in the more scientific aspects, the study will also perform molecular profiling on tumor samples to identify any genetic changes that might be linked to how well patients respond to the treatment or the likelihood of the cancer coming back.

    Participants in the study will be randomly assigned to one of the two treatment groups. Those in the first group will take mitotane daily for up to 2 years unless the cancer progresses or they experience unacceptable side effects. Those in the second group will take mitotane in the same way but will also receive cisplatin and etoposide through an IV for up to 4 cycles, each cycle lasting 21 days, unless the cancer progresses or they experience unacceptable side effects.

    After completing the treatment, patients will be followed up every 6 months to monitor their health and any signs of cancer recurrence.

    • MITOTANE
    • Etoposide
    • Cisplatin
  • Discovery of sorafenib and paclitaxel in the treatment of advanced adrenal cancer

    This clinical trial is focused on patients with Adrenocortical Carcinoma (ACC), a type of cancer that affects the adrenal glands. If a patient has ACC that has spread or cannot be removed by surgery, and if previous chemotherapy treatments haven’t worked, this study might be an option for them. The trial is testing a combination of two treatments: Sorafenib and Paclitaxel. Sorafenib is a pill taken twice a day, and Paclitaxel is given through an IV once a week. The goal is to see if this combination can help stop the cancer from growing.

    The main thing the doctors are looking to find out is if the cancer stops progressing in the first 4 months of treatment. They’re also interested in how long the treatment works, how it impacts the cancer, and any side effects that might be experienced. Another important part of the study is looking at how the treatment impacts the patient’s quality of life.

    The patient’s health will be closely monitored throughout the study, with the first check-up after 8 weeks and then every 12 weeks. This trial is a chance to try a new treatment combination that’s designed specifically for ACC patients who need more options.

    • Sorafenib
    • Paclitaxel
  • Adjuvant chemotherapy with or without mitotane in the treatment of high-risk postoperative adrenocortical carcinoma

    This trial is focused on patients who have undergone surgery for Adrenocortical Carcinoma (ACC), a rare type of cancer that affects the adrenal glands. The study is particularly interested in those who are at a high risk of the cancer coming back, which is often determined by a measure called Ki67. If Ki67 is 10% or higher, it means there’s a higher chance the cancer could return.

    The main goal of the trial is to compare different treatment approaches after surgery to see which is more effective at preventing the cancer from coming back. One treatment option includes a combination of chemotherapy drugs called Cisplatin and Etoposide, which may or may not be given alongside another drug called Mitotane. Mitotane is commonly used in this setting, but its effectiveness can depend on reaching certain levels in the blood, which can take time. The other option is to either give Mitotane alone or no additional treatment after surgery, depending on what the doctor thinks is best.

    The effectiveness of these treatments will be measured by looking at how long patients remain free from cancer after treatment, a period known as recurrence-free survival (RFS). This will be checked by regular scans of the chest, abdomen, and pelvis.

    • MITOTANE
    • Cisplatin
    • Etoposide
  • Discovering pembrolizumab for the treatment of advanced adrenocortical carcinoma

    This clinical trial is focused on exploring the effectiveness and safety of a medication called pembrolizumab, also known by its brand name Keytruda, in treating patients with a rare and aggressive type of cancer known as adrenocortical carcinoma. This cancer affects the adrenal glands located above the kidneys and has limited treatment options, especially in its advanced stages.

    The study is being conducted across multiple centers and is open to adults over 18 years old who have this type of cancer that has progressed despite receiving first-line chemotherapy treatments, specifically the EDP or EDP-M regimen, within the past 6 months. The treatment in this trial involves receiving pembrolizumab through an IV every three weeks at a dose of 200 mg. For those whose tumors are producing cortisol, additional medications like metyrapone or ketoconazole will be used to enhance the effectiveness of the immunotherapy.

    The main goal of this study is to see how well pembrolizumab works in treating this cancer, measured by the objective response rate, which looks at how much the cancer has shrunk or if it has disappeared after treatment. Other important aspects being looked at include how long patients live without their cancer getting worse, how long the benefits of the treatment last, overall survival, safety of the treatment, and its impact on the quality of life.

    This trial represents a hope for patients with advanced adrenocortical carcinoma, offering a potential new treatment option after other therapies have failed. It’s a significant step towards understanding and potentially improving the management of this challenging condition.

    • Pembrolizumab [Keytruda]
  • A study of cabozantinib in the treatment of advanced adrenocortical carcinoma

    This trial is focused on a medication called Cabozantinib-s-malate for patients with Advanced Adrenocortical Carcinoma, a rare and aggressive form of cancer that affects the adrenal glands.

    The study is designed to explore the effectiveness and safety of Cabozantinib, which is taken orally at a dose of 60 mg daily. This medication has shown promise in preliminary studies, where it helped some patients by either partially reducing the cancer or stabilizing it for four months or longer.

    The main goal of this trial is to see how well patients do after 4 months of treatment with Cabozantinib, specifically looking at whether their cancer has progressed or not. This is what doctors call progression-free survival.

    This trial is an opportunity for patients with advanced Adrenocortical Carcinoma to try a new treatment option that could potentially help manage their disease better than current therapies. It’s an open-label, phase II study, which means both the researchers and participants know what treatment is being given, and it’s at a stage where the focus is on evaluating the effectiveness and safety of the medication for a specific condition.

    • Cabozantinib-s-malate
  • To evaluate the effectiveness of cabazitaxel in the treatment of advanced adrenocortical carcinoma after previous treatment

    This trial is focused on exploring the effectiveness of a medication called Cabazitaxel for patients with a rare and aggressive type of cancer known as Adrenocortical Carcinoma (ACC). ACC is challenging to treat, especially in its advanced stages, and the options currently available have limited success. This study is particularly aimed at patients whose cancer has progressed despite undergoing previous chemotherapy treatments.

    Cabazitaxel is a drug that targets cancer cells by interfering with their ability to grow and divide. It is administered through an IV (intravenous) route every three weeks, with a total of up to six cycles of treatment planned. Each cycle of treatment lasts for three weeks, and the start of a new cycle depends on the patient’s recovery from any side effects, particularly focusing on blood cell counts and non-hair loss related side effects.

    An important aspect of this trial is that it does not allow the use of mitotane, a common medication for ACC, unless it is necessary for controlling hormone secretion by the tumor. The study will also look into how cabazitaxel behaves in the body, especially in patients who continue to take mitotane for hormone-related reasons compared to those who do not.

    The main goal of the study is to evaluate the effectiveness of cabazitaxel in improving the condition of patients with ACC after four months of treatment. This will be assessed through CT scans and compared to standard criteria for measuring cancer response to treatment.

    Patients participating in this trial will not be allowed to use certain other medications that could interfere with the study drug or be part of another clinical trial during this study. This study represents a hopeful step towards finding new treatment options for patients with advanced ACC, offering a chance to participate in pioneering research aimed at improving outcomes for this challenging condition.

    • Cabazitaxel