Brain CancerPhase 2NCT01113463
TPI 287 in Patients With Recurrent Glioblastoma Multiforme
A Phase 2 study testing TPI 287 in people with Brain Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if TPI 287 can help to control glioblastoma. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer
- What is being tested?
- TPI 287
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have histological or cytological documentation of GBM. Patients will be eligible if the original histology was lower grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made.
- Patients must have supratentorial GBM that has radiographic recurrence or progression following prior radiation therapy and temozolomide for GBM or lower grade glioma, or the appearance of new lesions on scan, or clinical or neurologic worsening despite stable disease on the last 2 scans.
- Patients must have measurable disease on radiologic scan.
- Patients must be >/= 18 years of age.
- Patients must have a Karnofsky performance status >/= 60%.
- Patients must have adequate bone marrow as evidenced by an absolute neutrophil count >/=1,500/uL and a platelet count >/=100,000/uL.
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- Patients must have adequate renal function as evidenced by serum creatinine <= the upper limit of normal (ULN)
- Patients must have adequate hepatic function as evidenced by serum total bilirubin </= 2.0 mg/dL and aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) </= 3 times the ULN.
- Patients must have recovered from the effects of any prior surgery, radiotherapy or other chemotherapy with any therapy related adverse events revolved to </= grade 1, and at least 12 weeks must have elapsed from the completion of radiotherapy, and 3 weeks from the last dose of Temozolomide.
- Women of child-bearing potential (includes women who are menopausal for less than 1 year and not surgically sterilized) must have a negative urine or serum pregnancy test at screening.
- Sexually active patients must agree to use adequate contraception (two barrier methods) for the duration of the study.
- Patients or their legal representative must be able to read, understand and sign an informed consent form (ICF).
Who cannot join
- Patients who have received more than one course of radiation therapy or more than a total dose of 65 grey (Gy). Patients may have received radiosurgery as part of the initial therapy (i.e., in addition to one course of radiation therapy); however, the dose used for the radiosurgery counts against the total dose limit listed above.
- Patients who have had a second surgery for recurrent disease who have no radiologically apparent residual disease (contrast-enhanced MRI imaging must have been performed within 24-48 hours post-operatively).
- Patient who have received any cytotoxic chemotherapy for treatment of GBM other than temozolomide (Gliadel trademarked as part of the initial therapy is permitted). However, patients who have received prior biologic therapy will be eligible.
- Patients who are receiving concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital and primidone) or who received EIAEDs within 2 weeks prior to the first dose of study drug.
- Patients who are not on a stable or decreasing steroid dose for the previous week prior to the study enrollment.
- Patients with an active infection or with a fever >/= 38.5°C within 3 days prior to the study enrollment.
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- Patients who have history of prior malignancy within the past 5 years except for curatively treated non-melanoma skin cancer or cervical intra-epithelial neoplasia for which the patient has been disease-free for at least 3 years.
- Patients with Grade 2 or higher peripheral neuropathy.
- Patients with New York Heart Association(NYHA) Class 3 or 4 congestive heart failure.
- Patients with known HIV or Hepatitis B or C.
- Patients who are pregnant or lactating.
- Patients with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the patient's ability to sign the ICF or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results.
- Patients who have received prior bevacizumab therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Open-Label Study of the Efficacy of TPI 287 in Patients With Glioblastoma Multiforme That Has Recurred or Progressed Following Prior Therapy With Radiation Plus Temozolomide
The goal of this clinical research study is to learn if TPI 287 can help to control glioblastoma. The safety of this drug will also be studied.
Read the detailed description
The Study Drugs:
TPI 287 is designed to block a protein that causes cancer cells to resist the effects of chemotherapy. By blocking the protein, the drug may be able to cause the cancer cells to shrink or stop growing.
Bevacizumab will be given to patients that are found to have brain damage, as described below. It is designed to block the growth of new blood vessels. It may help to lower the amount of brain damage related to tumor tissue death and help limit the symptoms of this condition.
Study Drug Administration:
On Day 1 of each 21-day study "cycle," you will receive TPI 287 by vein over about 1 hour.
If you experience intolerable side effects, the dose of TPI 287 may be lowered. Your doctor will tell you more about lowering a dose due to side effects.
To help prevent an allergic reaction to TPI 287, you will also receive the following drugs:
- Benadryl® (diphenhydramine) by vein over 30 minutes, 30-60 minutes before you receive TPI 287
- Cimetidine by vein over 30 minutes, 30-60 minutes before you receive TPI 287
- Either dexamethasone or methylprednisolone (taken by mouth 12 and 6 hours before you receive TPI 287; or by vein over 30 minutes at about 30-60 minutes before you receive TPI 287)
If you have an MRI scan that shows evidence of brain damage related to the tumor tissue death after you have received TPI 287 for two infusions, you will be eligible to receive bevacizumab. On Day 1 of Cycle 3 and beyond, if you are eligible, you will receive bevacizumab by vein over about 60-90 minutes.
Study Visits:
At each study visit, you will be asked about any drugs you may be taking and about any side effects you may have experienced.
On Day 1 of Cycle 1:
- Your weight and vital signs will be measured.
- If your doctor thinks it is needed, blood (about 1 tablespoon) will be drawn for routine tests.
On Day 1 of Cycles 2 and beyond:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests
On Day 15 of every even-numbered cycle (Cycles 2, 4, 6, and so on), you will have an MRI scan to check the status of the disease.
Length of Study:
You will be on study for up to 6 months. You may continue to receive the study drug for as long as you are benefiting. You will be taken off study if the disease gets worse or if you experience intolerable side effects.
If you are eligible and you receive it, you may continue to receive bevacizumab for as long as you are benefiting. You will be taken off bevacizumab if the disease gets worse or if you experience intolerable side effects.
End-of-Treatment Visit:
Within 28 days after you stop receiving the study drug, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:
- You will be asked about any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- You will have an MRI scan to check the status of the disease if you did not have one within 6 weeks before the end-of-treatment visit.
Long-Term Follow-Up:
Every 3 months for up to 1 year after you stop receiving the study drug, you will be called and asked about how you are feeling. Each phone call will last about 5-10 minutes.
This is an investigational study. TPI 287 is not FDA approved or commercially available. It is currently being used for research purposes only. Bevacizumab is FDA approved and commercially available for the treatment of brain tumors. The use of bevacizumab for brain damage related to the tumor tissue death is investigational.
Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Brain Cancer
- Being tested
- TPI 287
- Keywords
- Brain Tumor, Central Nervous System, CNS, Glioblastoma Multiforme, GBM, TPI 287, Radiation Therapy, Temozolomide, Chemotherapy, taxanes
- Medical subject headings
- Brain Neoplasms, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPI 287Drug
Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
| Study group | Role | What they receive |
|---|---|---|
| TPI 287 | Experimental | TPI 287 Starting dose 160 mg/m^2 intravenous (IV) every 3 weeks Receives: Drug: TPI 287 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) at 6 Months
PFS defined as number of participants alive without documented evidence of disease progression ("progression free") at 6 months. Progression-free survival calculated from the date of Day 1 Cycle 1 to the date that criteria for progression of disease is first seen. Progression is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Measured: 6 months (following nine 21-day cycles)
Secondary outcomes (1)
Number of Participants by Response Criteria
Complete Response (CR): Complete disappearance all measurable \& evaluable disease. No new lesions or evidence of non-evaluable disease. Partial Response (PR): >/= 50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, nor new lesions. Stable/No Response: Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 12 weeks duration. Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Unknown: Progression not been documented \& one or more measurable or evaluable sites have not been assessed.
Measured: Response obtained between days 15 and 21 of every even cycle and/or when clinically indicated, up to 6 months (approximately 9 completed cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionDec 2012
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cortice Biosciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Charles A. Conrad, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113463
- Sponsor's protocol ID
- 2009-0759
- Other IDs
- NCI-2011-01303
- Status last verified
- Sep 2016
- First submitted
- 27 Apr 2010
- Last updated
- 31 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label Study of the Efficacy of TPI 287 in Patients With Glioblastoma Multiforme That Has Recurred or Progressed Following Prior Therapy With Radiation Plus Temozolomide
- ClinicalTrials.gov ID
- NCT01113463
- Acronym / sponsor ID
- 2009-0759
- Conditions
- Brain Cancer
- Keywords
- Brain Tumor, Central Nervous System, CNS, Glioblastoma Multiforme, GBM, TPI 287, Radiation Therapy, Temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 17 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cortice Biosciences, Inc.
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if TPI 287 can help to control glioblastoma. The safety of this drug will also be studied.
Detailed description
The Study Drugs:
TPI 287 is designed to block a protein that causes cancer cells to resist the effects of chemotherapy. By blocking the protein, the drug may be able to cause the cancer cells to shrink or stop growing.
Bevacizumab will be given to patients that are found to have brain damage, as described below. It is designed to block the growth of new blood vessels. It may help to lower the amount of brain damage related to tumor tissue death and help limit the symptoms of this condition.
Study Drug Administration:
On Day 1 of each 21-day study "cycle," you will receive TPI 287 by vein over about 1 hour.
If you experience intolerable side effects, the dose of TPI 287 may be lowered. Your doctor will tell you more about lowering a dose due to side effects.
To help prevent an allergic reaction to TPI 287, you will also receive the following drugs:
- Benadryl® (diphenhydramine) by vein over 30 minutes, 30-60 minutes before you receive TPI 287
- Cimetidine by vein over 30 minutes, 30-60 minutes before you receive TPI 287
- Either dexamethasone or methylprednisolone (taken by mouth 12 and 6 hours before you receive TPI 287; or by vein over 30 minutes at about 30-60 minutes before you receive TPI 287)
If you have an MRI scan that shows evidence of brain damage related to the tumor tissue death after you have received TPI 287 for two infusions, you will be eligible to receive bevacizumab. On Day 1 of Cycle 3 and beyond, if you are eligible, you will receive bevacizumab by vein over about 60-90 minutes.
Study Visits:
At each study visit, you will be asked about any drugs you may be taking and about any side effects you may have experienced.
On Day 1 of Cycle 1:
- Your weight and vital signs will be measured.
- If your doctor thinks it is needed, blood (about 1 tablespoon) will be drawn for routine tests.
On Day 1 of Cycles 2 and beyond:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests
On Day 15 of every even-numbered cycle (Cycles 2, 4, 6, and so on), you will have an MRI scan to check the status of the disease.
Length of Study:
You will be on study for up to 6 months. You may continue to receive the study drug for as long as you are benefiting. You will be taken off study if the disease gets worse or if you experience intolerable side effects.
If you are eligible and you receive it, you may continue to receive bevacizumab for as long as you are benefiting. You will be taken off bevacizumab if the disease gets worse or if you experience intolerable side effects.
End-of-Treatment Visit:
Within 28 days after you stop receiving the study drug, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:
- You will be asked about any drugs you may be taking and if you have experienced any side effects.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- You will have an MRI scan to check the status of the disease if you did not have one within 6 weeks before the end-of-treatment visit.
Long-Term Follow-Up:
Every 3 months for up to 1 year after you stop receiving the study drug, you will be called and asked about how you are feeling. Each phone call will last about 5-10 minutes.
This is an investigational study. TPI 287 is not FDA approved or commercially available. It is currently being used for research purposes only. Bevacizumab is FDA approved and commercially available for the treatment of brain tumors. The use of bevacizumab for brain damage related to the tumor tissue death is investigational.
Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPI 287 | Experimental | Drug: TPI 287TPI 287 Starting dose 160 mg/m^2 intravenous (IV) every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have histological or cytological documentation of GBM. Patients will be eligible if the original histology was lower grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made.
- Patients must have supratentorial GBM that has radiographic recurrence or progression following prior radiation therapy and temozolomide for GBM or lower grade glioma, or the appearance of new lesions on scan, or clinical or neurologic worsening despite stable disease on the last 2 scans.
- Patients must have measurable disease on radiologic scan.
- Patients must be >/= 18 years of age.
- Patients must have a Karnofsky performance status >/= 60%.
Key exclusion criteria (13 listed)
- Patients who have received more than one course of radiation therapy or more than a total dose of 65 grey (Gy). Patients may have received radiosurgery as part of the initial therapy (i.e., in addition to one course of radiation therapy); however, the dose used for the radiosurgery counts against the total dose limit listed above.
- Patients who have had a second surgery for recurrent disease who have no radiologically apparent residual disease (contrast-enhanced MRI imaging must have been performed within 24-48 hours post-operatively).
- Patient who have received any cytotoxic chemotherapy for treatment of GBM other than temozolomide (Gliadel trademarked as part of the initial therapy is permitted). However, patients who have received prior biologic therapy will be eligible.
- Patients who are receiving concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital and primidone) or who received EIAEDs within 2 weeks prior to the first dose of study drug.
- Patients who are not on a stable or decreasing steroid dose for the previous week prior to the study enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPI 287Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days). | Drug | TPI 287 |
Primary outcome
Progression-Free Survival (PFS) at 6 Months
Time frame: 6 months (following nine 21-day cycles)
PFS defined as number of participants alive without documented evidence of disease progression ("progression free") at 6 months. Progression-free survival calculated from the date of Day 1 Cycle 1 to the date that criteria for progression of disease is first seen. Progression is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
1 secondary outcome
Number of Participants by Response Criteria
Time frame: Response obtained between days 15 and 21 of every even cycle and/or when clinically indicated, up to 6 months (approximately 9 completed cycles)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles A. Conrad, MD study chair
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TPI 287 in people with Brain Cancer, run by M.D. Anderson Cancer Center 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 13 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 31 Oct 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-Free Survival (PFS) at 6 Months (time frame: 6 months (following nine 21-day cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2016.