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

NCT02363647 | Terminated DMC

• 1 other identifier: GCO#1: 15-0146
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Medullary Thyroid Cancer; Colon Cancer

Keywords

medullary thyroid cancer; thyroid cancer; personalized therapy; personalized chemotherapy; individualized treatment; colon cancer; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  ORR as the sum of partial responses (PRs) and complete responses (CRs)

  up to 3 years

Secondary Outcomes (2)

• Progression-free Survival (PFS)

  up to 3 years

• Overall survival (OS)

  up to 3 years

Study Arms (1)

Tumor Genomic Analysis

EXPERIMENTAL

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

Interventions

Tumor Genomic Analysis OTHER

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.

Tumor Genomic Analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

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MeSH Terms

Conditions

Carcinoma, Medullary; Colonic Neoplasms; Thyroid Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Rectal Diseases

Study Officials

• Krzysztof Misiukiewicz, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Medicine, Hematology and Medical Oncology

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 16, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

US (1)