Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases
Generalized Malignancy, Primary
Drug: TPI 287
Procedure: Fractionated Stereotactic Radiotherapy (FSRT)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of TPI 287 Concurrent With Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases From Advanced Breast and Non-Small Cell Lung (NSCL) Cancer|
- Maximum Tolerated Dose (MTD) of TPI 287 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]MTD of TPI 287 given concurrently with Fractionated Stereotactic Radiotherapy (FSRT) to treat brain metastases from advanced solid tumors.
- Disease Control Rate (DCR) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]The percentage of participants with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents. Complete Response (CR): The tumor is no longer seen on two sequential MRI scans, and the patient is on no steroids or only adrenal-maintenance dose of steroids. Partial Response (PR): ≥ 50% decrease in the product of two diameters of target lesions on two sequential MRIs, taking as reference the baseline product of two diameters, provided that the patient has not had his/her dose of steroids increased since the last evaluation period. Stable Disease (SD): The scan shows no change, taking as reference the smallest product of diameters while on study. Patient should be receiving stable or decreasing doses of steroids.
- Progression Free Survival (PFS) Rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) definition of Progression follows. One or more of the following must occur: 20% or greater increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Experimental: Dose Escalation + Dose Expansion
Dose Escalation followed by Dose Expansion.
Dose Escalation Phase: The maximum tolerated dose (MTD) for TPI 287 given concurrently with Fractionated Stereotactic Radiotherapy (FSRT) will be determined using the standard 3+3 study design.
Dose Expansion Phase: Participants will be treated with TPI 287 at MTD given concurrently with FSRT to further assess toxicity and tumor response.
Drug: TPI 287
TPI 287 is an infusion given through veins. Dose escalation will begin at 14 mg/m^2/dose. Dose expansion will begin at the maximum tolerated dose (MTD).
Other Name: taxaneProcedure: Fractionated Stereotactic Radiotherapy (FSRT)
The prescription dose will be 25 gray (Gy) in 5 daily fractions delivered to the planning target volume (PTV).
Standard of care for treatment of patients with brain metastases, which are considered not surgically removable, is radiation therapy to the brain lesions. This treatment is called Fractionated Stereotactic Radiotherapy (FSRT) and is given without chemotherapy and usually over 5 days.
Researchers of this study want to find out if adding an investigational drug, called TPI 287, to standard radiation therapy (FSRT) can help people with brain metastases from cancer. TPI 287 is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02187822
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Tiffany Romershausen 813-745-2146 firstname.lastname@example.org|
|Principal Investigator: Solmaz Sahebjam, M.D.|
|Sub-Investigator: Prakash Chinnaiyan, M.D.|
|Sub-Investigator: Thomas Dilling, M.D.|
|Sub-Investigator: Jhanelle Gray, M.D.|
|Sub-Investigator: Amit Mahipal, M.D.|
|Sub-Investigator: Susan Minton, D.O.|
|Sub-Investigator: Nam Tran, M.D., Ph.D.|
|Sub-Investigator: Hyo Han, M.D.|
|Sub-Investigator: Hatem Soliman, M.D.|
|Sub-Investigator: John Arrington, M.D.|
|Principal Investigator:||Solmaz Sahebjam, M.D.||H. Lee Moffitt Cancer Center and Research Institute|