Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases

NCT ID: NCT02187822

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-09
• Study Completion Date: 2018-03-31

Brief Summary

The main purpose of this study is to see whether addition of TPI 287 to FSRT is safe and tolerable. Researchers also want to find out if adding TPI 287 to FSRT can help with better controlling the growth of brain lesions in people with brain metastases from their cancer.

Detailed Description

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).

Conditions

Brain Metastases; Generalized Malignancy, Primary; Brain Lesions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TPI 287

Intervention Type: DRUG

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).

Fractionated Stereotactic Radiotherapy (FSRT)

Intervention Type: PROCEDURE

The prescription dose will be 25 gray (Gy) in 5 daily fractions delivered to the planning target volume (PTV).

Interventions

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).

Intervention Type: DRUG

Fractionated Stereotactic Radiotherapy (FSRT)

The prescription dose will be 25 gray (Gy) in 5 daily fractions delivered to the planning target volume (PTV).

Intervention Type: PROCEDURE

Other Intervention Names

taxane

Eligibility Criteria

Inclusion Criteria

• Must have histologically or cytologically confirmed non-central nervous system primary solid malignancy.
• Must have pathologically or radiologically confirmed metastatic disease in the brain.
• Potential participants with up to 3 brain metastases (symptomatic and non-symptomatic) can be treated on this study. Maximum diameter of each brain lesion should be ≤ 5 cm. Maximum tumor volume ≤ 120 cc.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).
• Life expectancy of greater than 12 weeks.
• Patients requiring treatment with corticosteroids are eligible.
• Treatment with non-enzyme inducing anti-seizure medications is allowed.
• Must have normal organ and marrow function.
• Systemic chemotherapy washout period ≥ 7 days. For investigational dugs and monoclonal antibodies washout period ≥ 5x drug half-life. There are no limitations on number of prior treatment regimens.
• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of TPI 287 administration.
• Prior brain surgery or radiation is allowed as long as the metastatic lesion(s) to be targeted in this study has not previously been treated with radiation.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Patients who have had chemotherapy within 1 week (6 weeks for nitrosoureas or mitomycin C) or investigational therapies/monoclonal antibodies within 5 half-life of investigational compound or those who have adverse events which are greater than grade 1 and are due to agents administered more than 1 week earlier. Bisphosphonates, endocrine therapy, and trastuzumab are permitted without restriction.
• Are receiving any other investigational agents.
• Previous treatment of the target lesions with radiation therapy.
• Have previously been treated with whole brain radiation.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to TPI 287.
• Have brain metastases secondary to germ cell tumor or lymphoma malignancy.
• Women who are pregnant or nursing (lactating).
• Known contraindication to enhanced MRI and CT scan.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled seizure activity or psychiatric illness/social situations that would limit compliance with study requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cortice Biosciences, Inc.

INDUSTRY

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Solmaz Sahebjam, M.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MCC-17816

Identifier Type: -

Identifier Source: org_study_id