Overseen ByMichael Kluger, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Columbia University
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Objectives:
- To determine intraperitoneal (IP) progression free survival after optimal debulking and heated intraperitoneal chemotherapy (HIPEC) with cisplatin in patients with IP spread of adrenocortical cancer.
- Determine morbidity of this procedure in this patient population.
- Determine the impact of surgery and HIPEC on quality of life (QOL) and hormone excess.
- Examine patterns of recurrence (local versus systemic).
- Determine overall survival after optimal debulking and HIPEC in patients with IP spread of adrenocortical cancer.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it does mention that mitotane may be continued. It's best to discuss your specific medications with the trial team.
How is the HIPEC treatment for adrenocortical cancer different from other treatments?
HIPEC (hyperthermic intraperitoneal chemotherapy) with cisplatin is unique because it involves directly applying heated chemotherapy into the abdominal cavity after surgery to remove as much of the cancer as possible. This method is different from standard chemotherapy, which is usually given through the bloodstream, and it allows for higher concentrations of the drug to target cancer cells in the abdomen.
59101114Is HIPEC with Cisplatin safe for humans?
Cisplatin, used in various treatments, has been associated with side effects like nausea, vomiting, and kidney issues. However, these effects often subside after stopping the treatment. It's important to discuss potential risks with your doctor.
123612What data supports the effectiveness of the treatment HIPEC for Adrenocortical Cancer?
Cisplatin, a component of the HIPEC treatment, has shown good results in previous studies for adrenal cancer, and cytoreduction with intraperitoneal chemotherapy has improved survival in other advanced cancers.
347813Eligibility Criteria
This trial is for adults with Adrenocortical Carcinoma (ACC) where the majority of cancer is in the peritoneal cavity and can be surgically removed or treated with radiofrequency ablation. Participants must have a life expectancy over three months, practice birth control, and have adequate organ function. Excluded are those with severe heart, lung conditions, active infections, significant neuropathy, brain metastases or pregnant/breastfeeding women.Inclusion Criteria
My white blood cell count is healthy without needing medication.
I can perform daily activities with minimal assistance.
My scans show that my cancer can be surgically removed.
I am 18 years old or older.
My disease can be seen on a CT or PET scan.
My cancer is mainly in the belly area and can be surgically removed or treated with a special procedure.
Exclusion Criteria
I have severe lung disease with very low lung function test results.
I have moderate to severe nerve pain or damage.
I do not have major illnesses like heart disease, severe infections, or blood clotting disorders.
I weigh less than 30 kg.
My liver disease is at a moderate to severe stage.
I have a history of heart failure or my heart pumps less effectively.
I have or had brain metastases.
Participant Groups
The study tests if surgery followed by Heated Intraperitoneal Chemotherapy (HIPEC) using cisplatin improves survival without cancer spreading inside the abdomen. It also examines side effects, quality of life changes post-treatment and whether cancer comes back locally or spreads elsewhere.
1Treatment groups
Experimental Treatment
Group I: Surgery with HIPECExperimental Treatment3 Interventions
Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
πͺπΊ Approved in European Union as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
πΊπΈ Approved in United States as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
π¨π¦ Approved in Canada as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
π―π΅ Approved in Japan as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Columbia University Medical CenterNew York, NY
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
References
[Phase I study of a new antineoplastic agent, cis-diamminedichloroplatinum (II)]. [2013]Phase I study of cis-diamminedichloroplatinum(II) (CIS-DDP) was performed in 7 institution's clinical group using 40 patients with histologically proven urologic and gynecologic malignancies. The most characteristic adverse effects were nausea, vomiting, and anorexia. With the cessation of administration they disappeared within one or two days. Manifestation of hematopoietic and renal toxicities were found low. Hepatotoxicities were slight. In this study there were no cases who showed hearing disturbances and tinnitus, which were reported in rather high percentages. Acceptable doses of CIS-DDP for single and 5 days' consecutive administration were estimated 50 and 20 mg/m2/day respectively.
[Phase II study on cis-diamminedichloroplatinum (II) by a collaborative study]. [2013]Phase II study of cis-diaminedichloroplatinum(II) (CIS-DDP) administered intravenously was performed in 77 patients with urologic malignancies for the evaluation of clinical responses and adverse effects. The eligibility of the patients and evaluation of response were carried out according to the general criteria proposed by Drs. Koyama and Saito. Out of 85 patients, entered in this phase II study, 77 patients were considered evaluable. Complete responses were seen in 4 patients, 3 testicular tumor and 1 bladder cancer. Partial response were obtained in 24 patients; 10 bladder cancer, 8 testicular tumor, 5 prostatic cancer, and 1 renal cell carcinoma. Overall response rates were 73.3% in testicular tumor, 50.0% in bladder tumor, 20.8% in prostatic cancer, and 7.7% in renal cell carcinoma. Incidences of toxicities were noted in the gastrointestinal tract. Nausea, vomiting, anorexia, abdominal pain, and diarrhea were observed in 78.5% of the patients treated with CIS-DDP. Myelosuppression, lassitude, renal and hearing dysfunction were other prominent adverse effects.
Phase II trial of mitotane and cisplatin in patients with adrenal carcinoma: a Southwest Oncology Group study. [2017]Previous reports of chemotherapy in patients with adrenal cancer have described responses to cisplatin (CDDP). Because of these reports of good results, a phase II trial that used CDDP with and without mitotane (o,p'DDD) was initiated.
Adrenocortical carcinoma. [2013]Adrenocortical carcinoma is a rare disease with a poor prognosis. Patients can present with a hormonal syndrome or with general symptoms from an abdominal mass. The pathogenesis is unknown. Sometimes the adrenocortical carcinoma is associated with tumour syndromes such as the Beckwith-Wiedemann and Li-Fraumeni syndrome; however, most tumours are sporadic. Using one of the international classification methods, histopathological research can in almost all cases distinguish between adrenocortical adenoma and carcinoma. complete surgical resection is the treatment of choice for adrenocortical carcinoma. Mitotane is given when surgery is not possible, after incomplete resection or for metastatic disease. Frequently used chemotherapeutic combinations are etoposide, doxorubicin, cisplatin and mitotane (EDP/M) and streptozotocin and mitotane (SZ/M). International and national cooperation has resulted in a randomised trial aimed at determining a standard therapy in advanced adrenocortical carcinoma. The Dutch Adrenal Network is a national cooperation of endocrinologists, pathologists and oncologists from all eight academic centres and MΓ‘xima Medical centre. The network combines knowledge and expertise and gives patients the opportunity to receive optimal treatment in their own district.
Impact of surgical and clinical factors on the pharmacology of intraperitoneal doxorubicin in 145 patients with peritoneal carcinomatosis. [2013]Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are a combined treatment modality considered for selected patients with peritoneal carcinomatosis from colorectal and appendiceal cancer. Doxorubicin is a drug consistently used by our group in this clinical setting. The surgical and clinical factors that modify the pharmacokinetics of HIPEC may be important for the design of future perioperative chemotherapy regimens.
A histopathological study of nephrotoxicity, hepatoxicity or testicular toxicity: Which one is the first observation as side effect of Cisplatin-induced toxicity in animal model? [2021]Cisplatin (CP) is widely used in clinic to treat the solid tumors. However, CP is associated with some major side effects including nephrotoxicity, hepatoxicity, and testicular toxicity.
Systemic Therapy in Locally Advanced or Metastatic Adrenal Cancers: A Critical Appraisal and Clinical Trial Update. [2019]Mitotane and chemotherapy with etoposide, doxorubicin, and cisplatin plus mitotane (EDP-M) are the only therapies with demonstrated efficacy in advanced adrenocortical carcinoma. Prognostic and predictive factors are needed to identify patients who could obtain the best benefit from these treatments. Despite the strong rationale for their use, clinical trials on molecular targeted therapies have failed to demonstrate that these drugs are efficacious in the management of this extremely rare disease.
A Phase II Trial of Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Recurrent Adrenocortical Carcinoma. [2022]Recurrent adrenocortical carcinoma (ACC) is an aggressive disease with few options offering durable survival benefit. Despite metastasectomy, recurrence is common. Cytoreduction and intraperitoneal chemotherapy have offered improved survival in other advanced cancers. We sought to evaluate the use of cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) for the treatment of recurrent intraperitoneal ACC.
Hyperthermic intraperitonal chemotherapy is an independent risk factor for development of acute kidney injury. [2019]Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) or hyperthermic intrapleural chemotherapy (HIC) has been established as the new treatment modality for selected patients with peritoneal and pleural malignancies. The purpose of the study was to compare the development of acute kidney injury (AKI) in patients who received intravenous cisplatin alone, HIPEC and underwent surgery.
Evaluation and management of toxicity of cytoreductive surgery/hyperthermic intraperitoneal chemotherapy: the initial experience of a single centre study. [2021]Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a treatment modality for peritoneal surface malignancies with efficacy reported in many trials. Discrepancies, however, in the indication criteria, the extent of the surgical procedure, HIPEC regimens and toxicity evaluation represent a problem when comparing this method with other therapeutic modalities.
Indications for hyperthermic intraperitoneal chemotherapy with cytoreductive surgery: a clinical practice guideline. [2021]The purpose of the present review was to provide evidence-based guidance about the provision of cytoreductive surgery (crs) with hyperthermic intraperitoneal chemotherapy (hipec) in the treatment of peritoneal cancers.
Risk Factors for Cisplatin-Induced Nephrotoxicity: A Multicenter Retrospective Study. [2021]Cisplatin (CDDP)-induced nephrotoxicity is a concern in CDDP-based chemotherapy. The goal of this multicenter retrospective study was to identify potential risk factors for CDDP nephrotoxicity.
Supportive therapies in patients with advanced adrenocortical carcinoma submitted to standard EDP-M regimen. [2022]The management of patients with advanced/metastatic adrenocortical carcinoma (ACC) is challenging, EDP-M (etoposide, doxorubicin, cisplatin combined with mitotane) is the standard regimen. However, it is quite toxic, so an adequate supportive therapy is crucial to reduce as much as possible the side effects and maintain the dose intensity of cytotoxic agents.
Extensive Peritonectomy is an Independent Risk Factor for Cisplatin HIPEC-Induced Acute Kidney Injury. [2023]Cisplatin (CDDP)-containing hyperthermic intraperitoneal chemotherapy (HIPEC) is frequently applied in selected patients with peritoneal malignancies derived from ovarian cancer, gastric cancer, and primary peritoneal mesothelioma. HIPEC with CDDP increases perioperative morbidity, in particular by inducing acute kidney injury (AKI). Factors contributing to occurrence of AKI after intraperitoneal perfusion with CDDP have not been sufficiently evaluated.