Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 49 of 116 for:    medullary carcinoma

Personalized Cancer Therapy for Patients With Metastatic Medullary Thyroid or Metastatic Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02363647
Recruitment Status : Enrolling by invitation
First Posted : February 16, 2015
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Krzysztof Misiukiewicz, Icahn School of Medicine at Mount Sinai

Brief Summary:
The Personalized Discovery Process is the only program offering patients treatment recommendations based on an empirically constructed Drosophila "fly" model of their disease. Special committee selects one of the one of the few 2-3 FDA approved drug combinations or single agents that improved survival in the fly cancer model.

Condition or disease Intervention/treatment Phase
Medullary Thyroid Cancer Colon Cancer Other: Tumor Genomic Analysis Not Applicable

Detailed Description:
Tumor mutations identified by deep DNA and RNA sequencing of individual tumors are screened for tumor drivers, which are then incorporated into the "personal" Drosophila model and tested against a library of FDA approved drugs. Fly mortality is used as a surrogate for toxicity and increased survival to adulthood; improvements in tumor mutation-linked eye and/or wing abnormalities serve to quantify efficacy. This allows rapid and parallel screening of FDA approved drugs and subsequent drug combinations. The most efficacious and least toxic combinations are tested in xenograft models and a multidisciplinary tumor board of experts select the best therapeutic option. The objective is to demonstrate that the personalized drosophila model approach is superior to the current standard used in medullary thyroid or colorectal cancer.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Cancer Therapy for Patients With Metastatic Medullary Thyroid or Metastatic Colon Cancer
Study Start Date : January 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
Experimental: Tumor Genomic Analysis
Personalized Therapy Plan Patients with Metastatic Medullary or Colon Cancer being treated with the Personalized Treatment Plan developed during the different tumor genomic analysis study.
Other: Tumor Genomic Analysis
Tumor mutations identified by deep DNA and RNA sequencing of individual tumors are screened for tumor drivers, which are then incorporated into the "personal" Drosophila model and tested against a library of FDA approved drugs. Fly mortality is used as a surrogate for toxicity and increased survival to adulthood; improvements in tumor mutation-linked eye and/or wing abnormalities serve to quantify efficacy. This allows rapid and parallel screening of FDA approved drugs and subsequent drug combinations. The most efficacious and least toxic combinations are tested in xenograft models and a multidisciplinary tumor board of experts select the best therapeutic option. The objective is to demonstrate that the personalized drosophila model approach is superior to the current standard. Patient will be offered an unique "personalized" single drug or combination of drugs, all FDA approved, based on the Drosophila drug screening process.




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: up to 3 years ]
    ORR as the sum of partial responses (PRs) and complete responses (CRs)


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: up to 3 years ]
    The length of time during and after the treatment of disease that a patient lives with the disease but it does not get worse.

  2. Overall survival (OS) [ Time Frame: up to 3 years ]
    The length of time from either the date of diagnosis or the start of treatment for disease, that patients diagnosed with the disease are still alive.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients already enrolled to the separate Tumor Genomic Analysis and Molecular Testing for Personalized Cancer Therapy study, for which a personalized therapeutic plan has been successfully created under that protocol and selected by the multidisciplinary tumor board of experts for use in this therapeutic clinical trial
  • Histologically confirmed MTC by a Mount Sinai pathologist
  • Recurrent/metastatic or incurable MTC
  • Age > 18 years old
  • Life expectancy must exceed 1 year from enrollment in the study
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  • The subject has documented worsening of disease (progressive disease) at screening compared with a previous CT scan or MRI image done within 14 months of screening Documentation of progression may be made by CT, MRI, or PET assessment
  • Adequate organ and bone marrow function defined by routine testing
  • The subject has no other diagnosis of cancer (unless non-melanoma skin cancer, an early form of cervical cancer, or another cancer diagnosed ≥ 2 years previously) and currently has no evidence of active other malignancy (unless non-melanoma skin cancer or an early form of cervical cancer)
  • Signed and dated informed consent form indicating that the patient has been informed of all pertinent aspects of the trial prior to enrolment

Exclusion Criteria:

  • Patients who are currently receiving and responding to a different course of anti-neoplastic therapy, within the limits of acceptable toxicity per standard clinical practice, may not be enrolled to this study
  • Current symptomatic brain metastases. If previously present, the metastases must have been treated at least two months before participation in this study. CT or MRI scan of the brain is mandatory to assess the presence or not of brain metastases
  • History of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell, or squamous cell carcinoma of the skin
  • History of significant cardiac disease defined as:

    • Symptomatic CHF (NYHA classes III-IV)
    • High-risk uncontrolled arrhythmias; i.e. atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia or higher-grade AV-block (second degree AV-block Type 2 [Mobitz 2] or third degree AV-block)
    • Prolongation of QT interval > 480 msecs
    • History of myocardial infarction within last 12 months
    • Clinically significant valvular heart disease
    • Angina pectoris requiring anti-angina treatment
    • Current uncontrolled hypertension (persistent systolic > 180 mmHg and/or diastolic > 100 mmHg). Initiation or adjustment of antihypertensive medication is permitted prior to study entry
  • Evidence of active bleeding or bleeding diathesis
  • Cerebrovascular accident at any time in the past, transient ischemic attack, deep venous thrombosis or pulmonary embolism in the past 6 months
  • Current severe, uncontrolled systemic disease
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Failure to use contraception in patients with preserved reproductive capacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363647


Locations
Layout table for location information
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Layout table for investigator information
Principal Investigator: Krzysztof Misiukiewicz, MD Icahn School of Medicine at Mount Sinai

Publications:
Schoffski P, E.R., Muller S, Brose MS, Shah MH, Licitra LF, An international, double-blind, randomized, placebo-controlled phase III trial (EXAM) of cabozantinib (XL184) in medullary thyroid carcinoma (MTC) patients with documented RECIST progression at baseline. ASCO 2012, June 1-5, 2012.

Layout table for additonal information
Responsible Party: Krzysztof Misiukiewicz, Assistant Professor, Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02363647     History of Changes
Other Study ID Numbers: GCO#1: 15-0146
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Krzysztof Misiukiewicz, Icahn School of Medicine at Mount Sinai:
medullary thyroid cancer
thyroid cancer
personalized therapy
personalized chemotherapy
individualized treatment
colon cancer
colorectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms