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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02243592
Other study ID # NCI-2014-01585
Secondary ID NCI-2014-0158596
Status Active, not recruiting
Phase
First received
Last updated
Start date September 24, 2014
Est. completion date April 2, 2025

Study information

Verified date April 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This pilot research trial studies molecular profiling in tissue samples from patients with cancer who got better with treatment that didn't work for most other patients with the same disease. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to how well patients respond to treatment.


Description:

PRIMARY OBJECTIVES: I. To identify molecular indicators in malignant tissues from patients who were exceptional responders on clinical trials or standard systemic treatments using whole exome and/or targeted deep sequencing, as well as potentially other sequencing and other molecular characterization methods (if adequate tissue exists). II. To explore associations between the identified molecular indicators and the putative mechanism of action of the treatment received by the patient. III. To test the feasibility of identifying "exceptional responders", obtaining the relevant tumor and normal tissue and clinical data, and performing whole exome and/or targeted deep sequencing on these samples. OUTLINE: Previously collected tissue samples are analyzed via whole exome sequencing and/or targeted next generation sequencing (NGS) assay deep sequencing. Cases for which sufficient nucleic acid amounts are available will undergo additional analyses including whole genome sequencing, messenger ribonucleic acid (RNA) (mRNA)-sequencing, micro (miRNA) sequencing, promoter methylation analysis, and single nucleotide polymorphism (SNP) analysis.


Other known NCT identifiers
  • NCT02496195

Recruitment information / eligibility

Status Active, not recruiting
Enrollment 170
Est. completion date April 2, 2025
Est. primary completion date March 4, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Documented exceptional response, defined as patients meeting the following criteria: - Complete response to a regimen in which complete response is expected in < 10% of similarly treated patients - Partial response (PR) > 6 months in a regimen in which PRs > 6 months are expected in < 10% of patients with similar disease treated with same or similar regimen - Complete response (CR) or PR of unusual duration, such that the internal review committee considers it to be an exceptional response; examples below: - PR of duration > 3 x the median expected PR duration (in cases where PR is expected in > 10% of patients with the same disease treated with the same regimen) - CR or duration > 3 x the median expected CR duration (in cases where CR may be seen in > 10% of patients with same disease treated with same regimen) - The observed duration of CR (or PR) is longer than expected for 90% of patients with same disease treated with same regimen - Note: it is not required that the patient be enrolled on a clinical trial when the exceptional response was observed - Reports of radiologic scans or other evidence documenting response will be submitted for review; cases where response is not assessable (e.g. adjuvant treatment) will not be eligible because the outcome can not be attributed to a specific treatment - Treatment history must be available, for prior treatment and for the drug to which the exceptional response occurred - Patient must meet consent criteria; this requires: (i) current exceptional responder (ER) consent by a living participant not lost to follow-up, (ii) prior consent for future research by a participant not known to be deceased, but lost to follow-up, or (iii) if patient is deceased and did not decline to participate in research at the time of tissue removal for any tissue that would be used in this study, then no consent is required - Tumor sample available that meets study requirements - Required tumor samples MUST exist and be able to be submitted; investigators wishing to submit samples must not have made agreements that would prohibit the free use of data from such samples; the National Cancer Institute (NCI) will provide investigators with a letter for the collaborator amending their existing agreement to allow for the case to be submitted - Tumor tissue from prior to administration of the drug to which the exceptional response occurred is required; ideally this sample will have been collected just prior to treatment, but other prior tissue will be considered; tissue may be fresh frozen or formalin-fixed paraffin embedded - Tumor tissue amount must be at least a core biopsy, and meet minimum specimen requirements - Encouraged: normal tissue sample: (optional): blood or other specimen source for germline sequencing - The tumor samples and clinical data submitted to the Exceptional Responders Database in database in Genotypes and Phenotypes (dbGaP) will need to have appropriate agreements in place to allow for the submission; the Exceptional Responders Database can accept clinical data and samples from cases enrolled on a Cancer Therapy Evaluation Program (CTEP) sponsored clinical trial and cases that were not enrolled on any clinical trial; if the response occurred on a trial that was not CTEP-sponsored, there are existing agreements between the submitting site and the pharmaceutical company; if existing agreements do not allow for the submission of sample and clinical data, the NCI will provide the investigators with a letter that allows the tissue to be used for the exceptional responders study if signed by the appropriate collaborator; the letter modifies the existing agreement to include the CTEP Intellectual Property (IP) Option language that would allow the case to be submitted to the Exceptional Responders Database; if the existing agreement cannot be modified and the letter cannot be signed, the proposed case will not be accepted; Note: as stated above, the patient does not need to have been enrolled on a clinical trial to be eligible for the exceptional responders study Exclusion Criteria: - Patient's response did not meet criteria for an exceptional response - Patient's treatment regimen is expected to lead to CR or durable PR in > 10% of patients - Patient's duration of response is not > 3 x expected median length of response - Response not evaluable or not able to be attributed to systemic treatment (e.g. adjuvant treatment) - Patient refused consent for use of tissue for research activities included in the exceptional responders study - Tumor sample from prior to the exceptional response is not available, or does not meet quality metrics

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Laboratory Biomarker Analysis
Undergo sequencing and SNP analysis

Locations

Country Name City State
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States UCHealth University of Colorado Hospital Aurora Colorado
United States National Cancer Institute Developmental Therapeutics Clinic Bethesda Maryland
United States NCI - Center for Cancer Research Bethesda Maryland
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Trinity Health Medical Center - Brighton Brighton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Physicians' Clinic of Iowa PC Cedar Rapids Iowa
United States University of Virginia Cancer Center Charlottesville Virginia
United States Presence Resurrection Medical Center Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States John B Amos Cancer Center Columbus Georgia
United States Riverside Methodist Hospital Columbus Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States City of Hope Comprehensive Cancer Center Duarte California
United States Duke University Medical Center Durham North Carolina
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Poudre Valley Hospital Fort Collins Colorado
United States Kaiser Permanente-Fresno Fresno California
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Greenwich Hospital Greenwich Connecticut
United States Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas
United States Ben Taub General Hospital Houston Texas
United States Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee
United States Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma
United States University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin
United States UP Health System Hematology Oncology Marquette Marquette Michigan
United States UP Health System Marquette Marquette Michigan
United States WVUH-Berkely Medical Center Martinsburg West Virginia
United States Helen F Graham Cancer Center Newark Delaware
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Kaiser Permanente-Oakland Oakland California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Illinois CancerCare-Peoria Peoria Illinois
United States Phoenixville Hospital Phoenixville Pennsylvania
United States Kaiser Permanente Northwest Portland Oregon
United States Portsmouth Regional Hospital Portsmouth New Hampshire
United States Kaiser Permanente-Richmond Richmond California
United States University of Rochester Rochester New York
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States UCSF Medical Center-Mission Bay San Francisco California
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States CoxHealth South Hospital Springfield Missouri
United States Mercy Hospital Springfield Springfield Missouri
United States Springfield Clinic Springfield Illinois
United States Kaiser Permanente-Stockton Stockton California
United States Aurora Medical Center in Summit Summit Wisconsin
United States South Georgia Medical Center/Pearlman Cancer Center Valdosta Georgia
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Sibley Memorial Hospital Washington District of Columbia
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Chester County Hospital West Chester Pennsylvania
United States Reading Hospital West Reading Pennsylvania
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States York Hospital York Maine

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Molecular features in tissue samples from patients who were exceptional responders The molecular features of the tumors in the patients will be discernible as distinct to the tumor by comparison to (i) samples from normal tissue in the same patient and (ii) databases of similar data for normal and other tumor types. Baseline
Primary Putative mechanisms of action of the treatments that the patients received when they experienced their exceptional responses The associations between identified molecular features and the putative mechanisms of action of the treatments that the patients received when they experienced their exceptional responses will be explored. Statistical analyses will be primarily descriptive. Baseline
Primary Number of cases identified as potential exceptional responders Statistical analyses will be primarily descriptive. Baseline
Primary Percentage of identified potential cases confirmed to be exceptional responders Statistical analyses will be primarily descriptive. Baseline
Primary Percentage of confirmed exceptional responders for which adequate tissue with appropriate informed consent is acquired Statistical analyses will be primarily descriptive. Baseline
Primary Percentage of acquired cases with tissue for which at least the minimum molecular characterization is successfully obtained Statistical analyses will be primarily descriptive. Baseline
Primary Percentage of molecularly characterized cases for which a Molecular Characterization report identified (without reference to the drug received by the patient) at least one feature judged to have potential therapeutic relevance Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by an expert panel ("Panel") to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals. Baseline
Primary Percentage of cases with >= 1 feature on Molecular Characterization report that was judged to have potential therapeutic relevance to the specific class of drug the patient actually received when the exceptional response was experienced Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by the Panel to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals. Baseline
Primary Percentage of cases with >= 1 feature that correlates with the mechanism of action of the specific grant to which the exceptional response occurred that was found after further analyzing the molecular profile data for relevant molecular abnormalities Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by the Panel to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals. Baseline
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