Overview

Condition melanoma
Treatments srs, cognitive function tests, questionnaires
Phase phase 2
Sponsor M.D. Anderson Cancer Center
Start date August 2012
End date August 2018
Trial size 49 participants
Trial identifier NCT01644591, 2011-0875, NCI-2012-01349

Summary

The goal of this clinical research study is to find out if stereotactic radiosurgery (SRS) can control the disease in patients with more than 3 melanoma brain tumors.

SRS is the delivery of focused, high-dose radiation given in a single session to the tumors with a minimal dose given to uninvolved areas of the brain.

Recruiting in the following locations…

United States Texas
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dose based on largest diameter of the lesion as measured on the volumetric MRI, modified from RTOG 90-05 (7). Lesions targeted with 20-24 Gy for 2 cm, 16-18 Gy for >2 to 2.5 cm, and 12-16 Gy for >2.5-3.5 cm. SRS performed on day 1. 8 cognitive function tests given at baseline and at 1, 4, 6, 9, and 12 months after Day 1 of radiation treatment. 3 questionnaires regarding quality of life and symptoms given at baseline and at 1, 4, 6, 9, and 12 months after Day 1 of radiation treatment. It should take about 40 minutes to complete the questionnaires.
srs Stereotactic Radiosurgery
Lesions targeted with 20-24 Gy for 2 cm, 16-18 Gy for >2 to 2.5 cm, and 12-16 Gy for >2.5-3.5 cm on day 1.
cognitive function tests
7 cognitive function tests given at baseline and at 1, 4, 6, 9, and 12 months after Day 1 of radiation treatment.
questionnaires Surveys
3 questionnaires regarding quality of life and symptoms given at baseline and at 1, 4, 6, 9, and 12 months after Day 1 of radiation treatment. It should take about 40 minutes to complete the questionnaires.

Primary Outcomes

Measure
Time to Local Failure
time frame: 4 months
Neurocognitive Decline
time frame: 4 months

Secondary Outcomes

Measure
Overall Survival
time frame: 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. 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. 2. Greater than 3 presumed melanoma brain metastases on contrast-enhanced brain MRI scan obtained no greater than 4 weeks prior to study registration 3. Patients must be age >/= 18 years. 4. 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. 5. Patients must have KPS >/=70 6. Patients must be eligible to have all lesions treated as determined by the study radiation oncologist. 7. Patients must have adequate renal/hematologic function, as defined by creatinine clearance > 30ml/min and platelets>50,000. 8. 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. 9. Patients can be undergoing concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologist. Exclusion Criteria: 1. Patients are excluded if they have been treated with whole brain radiotherapy within the prior 3 months. 2. 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. 3. Patients are excluded if there is radiographic or cerebrospinal fluid (CSF) evidence of leptomeningeal disease. 4. 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). 5. Patients are excluded if there is any history of gadolinium allergy. 6. Patients are excluded if they are unable to obtain a Magnetic resonance imaging (MRI) scan for any other reason.

Additional Information

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
Principal investigator Erik P. Sulman, MD,PHD
Description Study Procedure: You will receive SRS on Day 1. There will be 1 day of treatment. You will sign a separate consent form for SRS that will explain the procedure and risks in detail. Study Visits: At 1, 6, and 9 months (+/- 14 days) after Day 1, the following tests and procedures will be performed: - You will have a physical exam, including measurement of your vital signs. - You will have an MRI to check the status of the disease. - You will complete the same 8 cognitive function tests and 3 questionnaires you completed at screening. At 4 and 12 months (+/- 14 days) after Day 1, the following tests and procedures will be performed: - You will have a physical exam, including measurement of your vital signs. - You will have an MRI to check the status of the disease. - You will have a whole body PET scan to check the status of the disease and to check the effects of the disease on your thinking and brain functions. - You will complete the same 8 cognitive function tests and 3 questionnaires you completed at screening. If the disease returns after treatment, you may receive additional SRS. Your treatment options will be discussed with you. Length of Study Participation: Your active participation on the study will be over when you have completed the Month 12 visit. If an MRI scan shows that you have more than 15 lesions, you will be withdrawn from the study. Your doctor(s) will discuss future treatment options with you. Follow-Up Visits: If the study doctor thinks it is needed, you will return to the clinic for follow-up visits. The following tests and procedures will be performed: - You will have a physical exam, including measurement of your vital signs. - You will be asked about any drugs you may be taking. - You will have an MRI to check the status of the disease. This is an investigational study. Up to 49 patients will take part in this study. All will be enrolled at MD Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.