By: ifood.tv

Preventative Trial of DFMO in Patients With High Risk Neuroblastoma in Remission

Apr 26, 2012 No Comments by

The purpose of this research study is to evaluate a new investigational drug to prevent
reoccurrence of neuroblastoma that is in remission. This study drug is called DFMO. The
objectives of this study will be to monitor for safety and look at efficacy of DFMO.

The safety of the proposed dosing regimen in this trial will be tested by an on-going
risk/benefit assessment during the study. A patient benefiting from treatment, not
progressing on therapy, and in the absence of any safety issues associated with DFMO may
continue on treatment with the expectation that there will be an overall clinical benefit.

The procedures involved in this study include Medical history, Physical exam, Vital signs
(blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the
tumor(s), MIBG scans, and Bone marrow aspirations. All of these tests and procedures are
considered standard of care for this population. Drug administration is also part of this
protocol, including an investigational new drug called DFMO.

The proposed dosing regimen is an oral dose of DFMO tablets two times a day for each day
while on study. There will be 24 cycles. Each cycle will be 28 days in length.

Clinical Trial Conditions: Neuroblastoma in Remission

Treatments in this Clinical Trial : DFMO

Clinical Trial Phase: Phase 2

Eligible Clinical Trial Participant Age : Between 0 years to 21 years

Can Healthy Volunteers Participate: No

Clinical Trial Lead Sponsor: Giselle Sholler

Detailed Clinical Trial Description: The purpose of this research study is to evaluate a new investigational drug to prevent
reoccurrence of neuroblastoma that is in remission. This study drug is called DFMO. The
objectives of this study will be to monitor for safety and look at efficacy of DFMO.

The safety of the proposed dosing regimen in this trial will be tested by an on-going
risk/benefit assessment during the study. A patient benefiting from treatment, not
progressing on therapy, and in the absence of any safety issues associated with DFMO may
continue on treatment with the expectation that there will be an overall clinical benefit.

The procedures involved in this study include Medical history, Physical exam, Vital signs
(blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the
tumor(s), MIBG scans, and Bone marrow aspirations. All of these tests and procedures are
considered standard of care for this population. Drug administration is also part of this
protocol, including an investigational new drug called DFMO.

The proposed dosing regimen is an oral dose of DFMO tablets two times a day for each day
while on study. There will be 24 cycles. Each cycle will be 28 days in length.

The clinical trial information was obtained from http://clinicaltrials.gov/ct2/show/NCT01586260

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By: ifood.tv