Surgical Resection of Latent Brain Tumors Prior to Recurrence

Study Purpose

This clinical trial evaluates the side effects and possible benefits of operating on brain tumors prior to the tumor coming back (recurrence). Understanding when surgery is most useful to patients with brain tumors is important. Some patients may undergo chemotherapy or radiation but still have visible tumor remaining after treatment. The purpose of this research is to compare outcomes of those who have surgery after chemotherapy or radiation, but prior to tumor recurrence, to those who have surgery at a different time, or no surgery at all.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age >= 18 years.
  • - Histological or cytological confirmation of brain tumor and/or suspected brain tumor based on clinical and radiologic findings.
  • - Prior chemotherapy and/or radiation treatment directed to the known/suspected tumor.
  • - Radiographic evidence of residual or previously unresected tumor.
  • - Willingness to undergo surgery and sign informed consent.
  • - Patients not currently eligible for an alternate competing interventional clinical trial.
  • - Enrollment in the Mayo Clinic Cancer Center Neuro-Oncology Program Registry for the study of Nervous System Tumors (IRB#12-003458)

    Exclusion Criteria:

    - Age < 18 years.
  • - Found to be a member of a vulnerable population (e.g. pregnant, lacking capacity to consent) during the course of pre-enrollment or pre-surgical assessment.
  • - Prior gross total resection of brain tumor leading to absence of visible latent disease (exemption available for post-operative enrollment) - Any contraindication to surgery, including anyone who in the opinion of the surgeon is at unreasonably elevated risk of wound complications.
  • - Avastin within the past 6 months for any reason.
- Patients who have not yet undergone surgery or radiation, but who would be appropriate candidates for an alternate interventional clinical trial (e.g. post-operative fractionated vs.single fraction radiation to the surgical cavity for surgical brain mets)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04810871
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Terry C Burns, M.D., Ph.D.
Principal Investigator Affiliation Mayo Clinic in Rochester
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Neoplasm
Study Website: View Trial Website
Additional Details

PRIMARY OBJECTIVE:

  • I. To evaluate the safety and feasibility of surgical resection for pre-recurrent brain tumors.
SECONDARY OBJECTIVES:
  • I. To determine whether there are differences in overall survival for patients who receive radiation therapy (RT) prior to surgery as compared to patients who receive RT after surgery or patients undergoing no further surgery.
  • II. To determine for patients having pre-recurrent surgery whether there is a longer interval to local/regional progression, any central nervous system (CNS) progression or need for subsequent intracranial treatment compared to patients receiving post-operative RT, time to each will be separately documented.
  • III. To determine for patients with pre-operative as compared to post-operative fractionated radiation for brain metastases (mets) whether there is a decreased rate of local recurrence.
  • IV. To determine for patients with pre-operative as compared to post-operative fractionated radiation for brain mets whether there is a decreased rate of leptomeningeal disease.
CORRELATIVE RESEARCH OBJECTIVES:
  • I. To determine the genetic and molecular alterations occurring in radiated brain and radiated tumor tissue compared to nonradiated tissue specimens (subjects will be matched to Mayo Clinic Cancer Center Neuro-Oncology Program Registry for the study of Nervous System Tumors 12-003458).
  • II. To investigate the relative sensitivity of radiated human CNS tumors to senolytic or other therapies in ex vivo assays targeting radiation-induced biology to promote synthetic lethality using cryopreserved or fresh tissue.
  • III. To investigate the availability and utility of candidate biomarkers reflective of tumor burden and therapeutic susceptibility, from tissue, cerebrospinal fluid (CSF) and peripheral blood.
  • IV. Patients self-reported outcomes may be obtained through the Neurosurgery Registry program.
As available, these data may be referenced as a screening tool for any impact on quality of life (QOL) associated with trial participation as compared to matched controls. OUTLINE: Patients undergo surgery as indicated clinically when applicable. After completion of surgery, patients are followed up at 3 and 6 months, and then every 6 months thereafter.

Arms & Interventions

Arms

Experimental: Treatment (surgery)

Patients undergo surgery as indicated clinically when applicable.

Interventions

Procedure: - Brain Surgery

Undergo surgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

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