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Brain MetastasesPhase 1NCT02187822

Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases

A Phase 1 study testing TPI 287 and Fractionated Stereotactic Radiotherapy (FSRT) in people with Brain Metastases and Generalized Malignancy, Primary, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TPI 287 and Fractionated Stereotactic Radiotherapy (FSRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
9 Oct 2014to 31 Mar 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

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

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.

Read the 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).

Being tested
TPI 287, Fractionated Stereotactic Radiotherapy (FSRT)
Keywords
Brain, Advanced solid tumors, Fractionated Stereotactic Radiotherapy (FSRT), Brain lesions, Primary solid malignancy
Medical subject headings
Brain Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TPI 287Drug

    Also called taxane

    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)Procedure or surgery

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

Study groups in NCT02187822
Study groupRoleWhat they receive
Dose Escalation + Dose ExpansionExperimentalDose 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.
Receives: Drug: TPI 287; Procedure: Fractionated Stereotactic Radiotherapy (FSRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Disease Control Rate (DCR)

    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.

    Measured: Up to 5 years

  2. Progression Free Survival (PFS) Rate

    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.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2014 (estimated)
  2. Study start9 Oct 2014
  3. Primary completion20 Feb 2018
  4. Study completion31 Mar 2018

Why it stopped: lack of funding by company providing TPI-287

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02187822
Sponsor's protocol ID
MCC-17816
Status last verified
Feb 2021
First submitted
9 Jul 2014
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TPI 287 and Fractionated Stereotactic Radiotherapy (FSRT) in people with Brain Metastases and Generalized Malignancy, Primary, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: lack of funding by company providing TPI-287). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of TPI 287 (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02187822.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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