Current Clinical Trials

Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
  1. Constantin Dasanu, MD, PhD
    Constantin Dasanu, MD, PhD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started March 2024
  5. Constantin Dasanu, MD, PhD
  6. Accepting new patients

Description

Summary

This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.

Official Title

S2013: Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study

Detailed Description

PRIMARY OBJECTIVE: I. To both develop and independently validate a risk prediction model for Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher non-hematological immune-related adverse events (irAEs) in the first year of immune checkpoint inhibitor (ICI)-based therapy for the treatment of solid tumors. SECONDARY OBJECTIVES: I. To prospectively assess the incidence of any grade of non-hematological irAEs and grade 4 hematological irAEs on ICI-based therapy. II. To observe th... more
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PRIMARY OBJECTIVE: I. To both develop and independently validate a risk prediction model for Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher non-hematological immune-related adverse events (irAEs) in the first year of immune checkpoint inhibitor (ICI)-based therapy for the treatment of solid tumors. SECONDARY OBJECTIVES: I. To prospectively assess the incidence of any grade of non-hematological irAEs and grade 4 hematological irAEs on ICI-based therapy. II. To observe the trajectory of patient-reported quality of life and health preferences over 12 months. III. To observe the trajectory of patient-reported adverse events over 12 months using serial assessment with select Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures. IV. To measure the burden of chronic, grade 1 and 2 toxicities using methods such as toxicity over time (ToxT). V. To track patterns of treatment of irAEs and patterns of toxicity resolution. TRANSLATIONAL MEDICINE OBJECTIVES: I. To evaluate the cytokine toxicity (CYTOX) score, a composite measure derived from 11 different cytokine levels, both prior to ICI-based therapy and after 1 cycle of ICI-based therapy as a predictive signature for the development of irAEs. II. To establish a repository of archival tissue and blood/serum specimens for potential predictive and/or prognostic markers of irAE risk. ADDITIONAL OBJECTIVE: I. To assess the feasibility of using electronic (e)PRO in a multi-center clinical trial setting. OUTLINE: Patients undergo collection of a tissue sample at the start of their routine cancer treatment. Patients complete questionnaires at the start of cancer treatment, weeks 4, 12, 24, and 52. Patients will have the option of providing blood samples at several time points during the study.

Keywords

Malignant Solid Neoplasm

Eligibility

for people 18 Years and up
Inclusion Criteria: Participants must be planning to receive ICI-based therapy for a solid tumor malignancy. This therapy must be given according to Food and Drug Administration (FDA) label or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A and not in the context of a clinical trial Participants who have received prior ICI-based therapy must have completed ICI based therapy at least 180 days prior to registration Participants must not have discontinued any prior ICI-b... more
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Inclusion Criteria: Participants must be planning to receive ICI-based therapy for a solid tumor malignancy. This therapy must be given according to Food and Drug Administration (FDA) label or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A and not in the context of a clinical trial Participants who have received prior ICI-based therapy must have completed ICI based therapy at least 180 days prior to registration Participants must not have discontinued any prior ICI-based therapy (if applicable) because of irAE Participants must not have received chemotherapy, biologic, or targeted-therapy within 21 days prior to registration Participants must have recovered from side effects of prior therapy to the following standards per treating physician's discretion: =< Grade 1 for any non-hematologic side effects (excluding neuropathy and alopecia); lab-related parameters of liver and renal function will be considered at the discretion of the treating physician) =< Grade 2 for neuropathy and/or alopecia Grade 3 or less for any hematologic side effects Participants must be planning to begin standard of care ICI-based therapy within 3 calendar days after registration Participants must not be planning to receive ICI-based therapy in combination with chemotherapy or any other non-ICI therapy for treatment of their cancer Participants must be at least 18 years of age Participants must complete their history and physical examination within 28 days prior to registration Participants who can complete the S2013 Feasibility Questionnaire in English or Spanish must participate at the scheduled assessments Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English, Spanish, or French and must be planning to complete PROs at all scheduled assessments Participants must complete the pre-registration (baseline) PRO forms within 14 days prior to registration Participants must be willing to participate in PRO data collection Note: Prior to registration, participants must decide on their method (paper or electronic) of completing their follow-up questionnaires. Participants who elect electronic (ePRO) completion must have an iPhone, Android phone, or tablet with cellular or WiFi connectivity in order to download the Patient Cloud mobile applications onto the device (personal device or a site provisioned device for multi-users) Participants must be offered the opportunity to participate in the optional specimen banking Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system. Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

Lead Scientists at Eisenhower Health

Constantin Dasanu, MD, PhD
Board Certified Medical Oncologist and Hematologist, Constantin Dasanu, MD, PhD, is dedicated to providing personalized cancer care for his patients and their families. He received his M.D. degree summa cum laude from the Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, and his Ph.D. in Immunology from the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. He completed his residency in Internal Medicine at the Albert Einstein College of Medicin... more
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Board Certified Medical Oncologist and Hematologist, Constantin Dasanu, MD, PhD, is dedicated to providing personalized cancer care for his patients and their families. He received his M.D. degree summa cum laude from the Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, and his Ph.D. in Immunology from the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. He completed his residency in Internal Medicine at the Albert Einstein College of Medicine in New York and his fellowship in Hematology/Oncology at New York Medical College. Dr. Dasanu also completed his training in Hematology & Transfusion Medicine in his home country Romania. 

“My immunology background offers me a unique clinical perspective as contemporary cancer therapies include a multitude of targeted agents, monoclonal antibodies, various biologics and vaccines,” states Dr. Dasanu. He treats patients with a variety of solid cancers, malignant melanoma and blood conditions. He serves as Director of Hematologic Malignancies at Eisenhower Lucy Curci Cancer Center (ELCCC). 

Dr. Dasanu is a Clinical Professor of Medicine at the University of California in San Diego, a major collaborative affiliate of ELCCC. He is the Director of Research at ELCCC and a principal investigator for a number of clinical trials. He presents his research findings at national and international conferences. He is the recipient of several teaching awards including the prestigious Thomas R. Preston MD Excellence in Teaching Award at the University of Connecticut in 2011. 

A prolific medical writer, Dr. Dasanu published more than 200 scientific and scholarly articles in prominent specialty journals including Journal of Clinical Oncology, New England Journal of Medicine, Journal of Thoracic Oncology and British Journal of Haematology among others. He is the editor of oncology sections at the Expert Opinion on Pharmacotherapy, Expert Opinion on Biological Therapy, and Current Medical Research and Opinion. He is a peer reviewer for Blood Journal and Leukemia Research. 

Armed with the knowledge of science, Dr. Dasanu feels that he can make a real difference in the lives of his patients. “The field is constantly changing and, therefore, I keep learning and constantly applying the most up-to-date, state-of-the-art treatments which ultimately benefit my patients,” states Dr. Dasanu. “My role is one of providing my patients with a medical plan that offers hope, but not false hope. Treating patients as unique individuals, with respect and compassion, and treating them as I would want to be treated are my ultimate goals in patient care.”

Clinical Study Details

  1. Accepting new patients
  2. study started March 2024
  3. Observational
  4. April 04, 2024