Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases

NCT02187822 | Terminated Phase 1 FDA Drug

• 1 other identifier: MCC-17816
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases; Generalized Malignancy, Primary; Brain Lesions

Keywords

Brain; Advanced solid tumors; Fractionated Stereotactic Radiotherapy (FSRT); Brain lesions; Primary solid malignancy

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of TPI 287

  MTD of TPI 287 given concurrently with Fractionated Stereotactic Radiotherapy (FSRT) to treat brain metastases from advanced solid tumors.

  Up to 2 years

Secondary Outcomes (2)

• Disease Control Rate (DCR)

  Up to 5 years

• Progression Free Survival (PFS) Rate

  Up to 5 years

Study Arms (1)

Dose Escalation + Dose Expansion

EXPERIMENTAL

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; Procedure: Fractionated Stereotactic Radiotherapy (FSRT)

Interventions

TPI 287 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).

Also known as: taxane

Dose Escalation + Dose Expansion

Fractionated Stereotactic Radiotherapy (FSRT) PROCEDURE

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

Dose Escalation + Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Cortice Biosciences, Inc.: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Neoplasm Metastasis

Interventions

TPI-287; taxane

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Solmaz Sahebjam, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 11, 2014
• Study Start: October 9, 2014
• Primary Completion: February 20, 2018
• Study Completion: March 31, 2018
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

US (1)