Brain Surgery for Relapse

Phase-Based Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Rochester, Rochester, MN
Relapse+2 More
Brain Surgery - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Relapse

Study Summary

This study is evaluating whether surgery is more effective when performed after chemotherapy or radiation.

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Eligible Conditions

  • Relapse
  • Recurrence
  • Brain Cancer
  • Neoplasms, Brain
  • Brain Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Brain Surgery will improve 2 primary outcomes and 6 secondary outcomes in patients with Relapse. Measurement will happen over the course of Up to completion of surgery.

Year 5
Overall survival
Year 5
Progression free survival
Year 5
Time to subsequent treatment (i.e. chemotherapy/immunotherapy and/or radiation)
Up to 5 years
Feasibility of surgical resection by short and long term outcomes
Incidence of adverse events
Rate of leptomeningeal disease
Rate of local recurrence
Up to completion of surgery
Neurosurgical morbidity

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment (surgery)

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Brain Surgery is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Treatment (surgery)
Procedure
Patients undergo surgery as indicated clinically when applicable.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Who is running the study

Principal Investigator
T. B.
Terry Burns, Principal Investigator
Mayo Clinic

Closest Location

Mayo Clinic in Rochester - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Relapse or one of the other 2 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Someone who has had chemotherapy and/or radiation treatment directed at a tumor is eligible for surgery if there is radiographic evidence of residual or previously unresected tumor show original
are being asked to consider a therapy investigational agent, Gleevec People not currently eligible for a different, experimental clinical trial are being asked to consider taking a drug called Gleevec. show original
We are enrolling patients with nervous system tumors in a research study show original
Age >= 18 years
The text implies that a brain tumor is confirmed through a histological or cytological examination of tissue samples from the brain. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary cause of relapse?

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The primary causes of relapse was an increase in the expression of Bcl-2, p27, cyclin D1, c-myc, p-PI3K, p-Akt and a decrease of cyclin A and p21.

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What are common treatments for relapse?

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The study has shown that a wide variety of different treatments exist for relapsed systemic lupus erythematosus. Patient selection would be critical in improving treatment.

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How many people get relapse a year in the United States?

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Each year, nearly a million Americans experience some form of relapse of their arthritis. Around two thirds of people with arthritis relapse within 3 years of first diagnosis.

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What causes relapse?

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People who relapse for any reason have a greater risk of dying from a second cancer within a year or two than those who do not. Other studies showed higher-than-expected relapse rates among people treated on one-off trial. The present study found that in the short-term there was a significant impact of having had a full-dose course on patients' relapse rates. Thus, it can now be concluded that relapse rates in the short-term are higher than anticipated because patients on a full-dose course have greater relapse risk than those on a low-dose course.

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What is relapse?

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Relapse to a previous remission occurs frequently in bipolar II disorder and is associated with the presence of psychotic symptoms. Identifying factors that predict relapse in this patient population could enhance the ongoing quest to eradicate the illness from the clinic.

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What are the signs of relapse?

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During the year preceding the study, the authors noticed worsening psychosis and depression. In relapse, there can be sudden onset of new psychotic experiences with onset of depression, or can be sudden onset of depressive symptoms such as feeling low in mood, feeling exhausted, or having trouble concentrating. There can also be worsening insomnia due to stressors. These factors can be a marker of relapse.

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Can relapse be cured?

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Relapse of arthritis is common. However, many cases are manageable with low dose, long acting anti-TNF medication, low dose NSAID and/or DMARDs and/or biologic anti-TNF.

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Have there been any new discoveries for treating relapse?

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In recent two decades, we have seen a dramatic increase in research to address relapse therapy. Yet, there is still not general consensus about what should be investigated to treat relapse. Current findings show that there are few methods that could potentially treat relapse efficiently. However, they still remain inconclusive. We need well-designed randomized studies to compare different therapies. Furthermore, clinical trials on patients with severe illnesses are not available. [A recent study(http://www.keckmedicine.org/has-any-experimental-treatment-for-relapse-worked)] is still a challenge as it is difficult to carry out well-designed trials on such patients.

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What is brain surgery?

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Brain surgery is a new approach of treating cancer. Unfortunately, the cost of brain surgery, with regard to number of patients treated and the side effects of the operation, is too high. Therefore, we recommend performing brain surgery only when the benefits of the surgery are high.

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Have there been other clinical trials involving brain surgery?

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The most recent clinical trials in which brain surgery was used in breast cancer patients include the [Lacazella] (https://www.clinicaltrials.gov/ct2/Results). Recent findings of the [Lacazella] are encouraging and have shown brain tumor reoccurrence at a rate lower than other studies of treatments. However, more clinical trials are needed to have a more better definition to the brain surgery for use in brain metastasis. For patients who are willing to join a clinical trial, Power can help you search recent trials by condition or surgery that has the potential to be helpful for your condition or surgery.

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What are the latest developments in brain surgery for therapeutic use?

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Brain surgery for therapeutic use remains a well-established technique and a safe method for treatment of a variety of neurosurgical conditions especially in children. The number of indications for brain surgery increased. Furthermore, new surgical techniques improved results.

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Does relapse run in families?

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This report on the families investigated supports the family based approach to preventive healthcare. As the number of patients with familial clustering in our study was small, our conclusion should be extended to familial clustering of this condition in the general population.

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