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Stereotactic Radiosurgery in Treating Patients With Greater Than 3 Melanoma Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01644591
Recruitment Status : Recruiting
First Posted : July 19, 2012
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase II trial studies how well stereotactic radiosurgery works in treating patients with melanoma that has spread to more than 3 places in the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

Condition or disease Intervention/treatment Phase
Clinical Stage IV Cutaneous Melanoma AJCC v8 Metastatic Malignant Neoplasm in the Brain Metastatic Melanoma Pathologic Stage IV Cutaneous Melanoma AJCC v8 Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Stereotactic Radiosurgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial to Determine Local Control and Neurocognitive Preservation After Initial Treatment With Stereotactic Radiosurgery (SRS) for Patients With >3 Melanoma Brain Metastases
Actual Study Start Date : August 2, 2012
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Treatment (SRS)
Patients undergo SRS on day 1.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Stereotactic Radiosurgery
Undergo SRS
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • stereotactic radiation therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery




Primary Outcome Measures :
  1. Time to progression [ Time Frame: Up to 12 months ]
    Time to local failure will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of local failure rate in patients treated with stereotactic radiosurgery (SRS) to null hypothesis with respect to the time to local failure. Patients who are lost to follow-up or who die from distant disease before having local failure will be censored. Local control rates at 4 months may be estimated with 95% confidence intervals using Kaplan-Meier method.

  2. Time to neurocognitive failure [ Time Frame: Up to 12 months ]
    The baseline Listening Vocabulary Levels Test-Revised (HVLT-R) score will be compared to the HVLT-R score in patients surviving 4 months. Preservation of function is defined as improvement of HVLT-R score or decline by 4 points or less. Failure is defined as decline by 5 or more points. Time to neurocognitive decline will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in patients treated with SRS to null hypothesis with respect to the time to neurocognitive decline. Patients who are lost to follow-up or who die before having neurocognitive decline will be censored. Rates of neurocognitive decline at 4 months may be estimated with 95% confidence intervals using Kaplan-Meier method.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 12 months ]
    Will be estimated using the product-limit estimator of Kaplan and Meier. Cox proportional hazards regression will be used to model overall survival as a function of age, Karnofsky performance status, extra-cranial disease, and BRAF mutation status. Will model time to local failure, time to distal failure, and time to neurocognitive decline using competing risk regression when death without events is considered as a competing risk.

  2. Neurocognitive function score [ Time Frame: Up to 12 months ]
    Will use descriptive statistics and boxplots to summarize and illustrate the neurocognitive function score at each assessment time. Will similarly summarize and illustrate the change from baseline in neurocognitive function score. Will also fit the neurocognitive data with a general linear model including the baseline score as covariates to assess differences in neurocognitive scores over time (to 4 months) for those patients that are alive and progression-free at 4 months. We will also model the data with mixed effects regression including baseline HVLT-R, time, number of lesions, extra-cranial disease, and a patient specific random effect. Will use logistic regression methods to model the logit of the probability of neurocognitive decline as function of ApoE (i.e., Apo E2, Apo E3, Apo E4) genotyping, inflammatory markers, hormone growth factors.

  3. Number of cycles of systemic chemotherapy given following radiation treatment [ Time Frame: Up to 12 months ]
    Will use descriptive statistics to summarize the number of cycles of systemic chemotherapy given following radiation treatment for each treatment arm.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with histologic proof of malignant melanoma. Histologic confirmation may be from the primary tumor site, or from another metastatic site (systemic lymph node, etc). Cytology-alone is not an acceptable method of diagnosis
  • Greater than 3 presumed melanoma brain metastases on contrast-enhanced brain MRI scan obtained no greater than 4 weeks prior to study registration
  • Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
  • Patients must have Karnofsky performance status (KPS) >= 70
  • Patients must be eligible to have all lesions treated as determined by the study radiation oncologist
  • Creatinine clearance > 30 ml/min
  • Platelets > 50,000
  • Patients should have normal coagulation (international normalized ratio [INR] < 1.3) and be able to withhold anticoagulation/antiplatelet medications a minimum of 24 hours prior to radiosurgery treatment (or until INR normalizes), on the day of treatment and 24 hours after radiosurgery treatment has concluded
  • Patients can be undergoing concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologist

Exclusion Criteria:

  • Patients are excluded if they have been treated with whole brain radiotherapy within the prior 3 months
  • Patients are excluded if they have a history of metastatic cancer in addition to melanoma or a history of uncontrolled non-metastatic cancer. Patients with localized squamous cell carcinoma and/or basal cell carcinoma are not excluded
  • Patients are excluded if there is radiographic or cerebrospinal fluid (CSF) evidence of leptomeningeal disease
  • Female patients of childbearing age are excluded if they are pregnant as determined with a serum beta HCG no greater than 14 days prior to study registration, or breast-feeding. (The exclusion is made because gadolinium may be teratogenic in pregnancy)
  • Patients are excluded if there is any history of gadolinium allergy
  • Patients are excluded if they are unable to obtain a magnetic resonance imaging (MRI) scan for any other reason

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): NCT01644591


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jing Li    713-563-2300      
Principal Investigator: Jing Li         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Erik P Sulman M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01644591    
Other Study ID Numbers: 2011-0875
NCI-2018-01809 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2011-0875 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2012    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neoplasms
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases