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Registry Study for Personalized Cancer Therapy

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ClinicalTrials.gov Identifier: NCT02508662
Recruitment Status : Recruiting
First Posted : July 27, 2015
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Objectives:

Primary Objectives:

To evaluate the anti-cancer activity of commercially available, targeted anti-cancer therapies used off-label for treatment in patients with advanced solid cancer with known genomic aberrations.

Secondary Objectives:

To determine outcomes of patients who were treated with matched targeted anti-cancer therapies based on known genomic aberrations.

To obtain treatment related adverse events in patients with advanced solid tumor who were treated with off -label targeted therapies.

To determine co-genomic aberrations that may contribute to treatment response or resistance mechanisms.

To determine feasibility of detecting the genomic alterations in plasma, and the genomic evolution of circulating biomarkers.


Condition or disease Intervention/treatment
Advanced Cancers Solid Tumors Other: Review of Screening Tests and Molecular Test Results

Detailed Description:

Study Treatment Assignment:

If you are found to be eligible to take part in this study, the study doctor will review the test results in your medical records that were previously performed as part of your routine care. The results of the testing may be helpful in managing your treatment and may also help the doctor to find effective off-label use of FDA approved therapies for the type of cancer you have.

After reviewing the screening tests and the molecular test results in your medical records, the study staff and your study doctor will work together to find an off-label use for an FDA approved therapy that is best for you. You may receive a single therapy or a combination of therapies. You and the study doctor will discuss this.

The study doctor or study staff will tell you which drug(s) you will be taking, the dose of the study drug(s), and how often you should take them. You will sign a separate consent form that explains in more detail how the study drug(s) are administered and the potential benefits and side effects of taking the study drug(s).

Study Visits:

While you are receiving treatment and during follow-up, you will have your routine, standard of care clinic visits and routine tests so that the doctor may check the status of the disease to learn if the therapy chosen to treat the disease is having any effect. Information from these routine visits will be collected and stored by the study staff. The timing of these visits will depend on the type of therapy you receive.

During every cycle of therapy (about every 3-4 weeks):

  • You will have a physical exam.
  • Blood (about 2 teaspoons) will be drawn for routine tests.
  • If your doctor thinks it is needed, urine will be collected for routine tests.
  • If your doctor thinks it is needed, you will have an EKG to check the health of your heart.

After even numbered cycles (2, 4, 6, and so on), or more often if the doctor thinks is it needed, you will have the same imaging scan(s) which were done during Screening to check the status of the disease.

This is an investigational study.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry Study for Personalized Cancer Therapy
Actual Study Start Date : July 2015
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Group/Cohort Intervention/treatment
Advanced Cancer (Refractory) with Genomic Mutation
Participants with advanced cancer who have exhausted standard treatment option and have no potential clinical trial available, and who have potentially actionable alterations on genomic profiling.
Other: Review of Screening Tests and Molecular Test Results
Review of screening tests and molecular test results in participant's medical records. Study staff and study doctor work together to find an off-label use for an FDA approved therapy that is best for participant.




Primary Outcome Measures :
  1. Tumor Response [ Time Frame: 8 weeks ]

    Evaluation of tumor: the same imaging technique used during the initial evaluation or more sophisticated studies performed once after 2 cycles.

    Patients with measurable disease assessed by standard RECIST (Version 1.1).



Biospecimen Retention:   Samples With DNA
Blood (about 4 teaspoons) drawn to check for any genetic mutations.


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.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with advanced solid cancer with known genomic aberrations at MD Anderson Cancer Center.
Criteria

Inclusion Criteria:

  1. Patients with advanced or metastatic cancer that is refractory to standard therapy or that has relapsed after standard therapy or has no standard therapy that increases survival by at least three months.
  2. Patients with a potentially actionable genomic alteration.
  3. All prior treatment-related toxicities must be resolved to CTCAE (Version 4.0) < or = Grade 2 (except alopecia) at the time of screening.
  4. Patients willing to sign informed consent.
  5. Patients under the age of 18 years old are allowed as long as the safety profile of the drug is established in the pediatric population.

Exclusion Criteria:

  1. Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.
  2. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to planned treatment drug.
  3. Rapidly progressing leptomeningeal or brain metastases or spinal cord compression.
  4. Clinical trial (including targeted and/or non-targeted) other than registry study is available; patient is willing and eligible to enroll in such trial.

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): NCT02508662


Contacts
Contact: Funda Meric-Bernstam, MD 713-745-4453

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Funda Meric-Bernstam, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02508662     History of Changes
Other Study ID Numbers: 2015-0300
NCI-2015-01453 ( Registry Identifier: NCI CTRP )
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Solid Tumors
Genomic Mutations
FDA Approved Off-Label Chemotherapy
Refractory