Brain TumorPhase 1NCT00584883
A Phase I Study of ABT 510 for Newly Diagnosed Glioblastoma Multiforme
A Phase 1 study testing ABT 510 in people with Brain Tumor, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
To determine the maximum tolerated dose of ABT 510 when administered concurrent with radiation therapy for patients with newly diagnosed glioblastoma multiforme. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- ABT 510
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Jul 2008
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 19 years of age or older.
- Patients must have histologically proven newly diagnosed glioblastoma multiforme.
- Patients must have fully recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen for 5 days prior to entry.
- Patients must have a Karnofsky performance status > 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
- Patients must have adequate hematologic, renal and liver function (i.e. Absolute neutrophil count > 1500/mm3, Platelets > 100,000/mm3, creatinine 1.5 mg/dl .
- Women of childbearing potential must have a negative pregnancy test.
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- Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. The effect of the investigational drugs on the developing human fetus is not known, but these drugs are likely to be harmful to the developing fetus or nursing infant. Women of child-bearing potential must agree to use adequate contraception (either surgical sterilization; approved hormonal contraceptives such as birth control pills Depo-Provera, or Lupron Depot; barrier methods such as condom or diaphragm along with spermicide; or an Intrauterine device (IUD)). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and study PI immediately.
- The patient is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Pregnant or breast feeding.
- Prior therapy for the brain tumor (except surgery)
- Prior treatment with antineoplastic agents.
- Exclude sexually active males and females unwilling to practice contraception during the study.
- Serious concurrent infections.
- Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias ) or myocardial infarction within the last 12 months.
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- Patients who have had prior cytotoxic chemotherapy prior to radiation therapy.
- Patients with other serious uncontrolled co-morbid diseases that the investigator feels may comprise the study findings.
- Patients must be able to learn to self -administer or have another person administer subcutaneous(SQ) injections.
- Patients who have received any other investigational agents within the 28 days prior to Day 1 of the study.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: A Phase I Study of ABT 510 and Concurrent Temozolomide and Radiotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme
To determine the maximum tolerated dose of ABT 510 when administered concurrent with radiation therapy for patients with newly diagnosed glioblastoma multiforme.
Read the detailed description
- To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme.
- To determine the duration of disease free survival and overall survival associated with this therapy.
- Evaluate thrombospondin 1 (TSP-1) and 2 (TSP-2) in tumor vs. corresponding normal tissue using quantitative real time Polymerase Chain Reaction (Q-RT-PCR).
- Determine the effect of ABT 510 on tumor permeability and tumor blood volume as measured by non-invasive Magnetic Resonance Imaging (MRI).
- Conditions
- Brain Tumor
- Being tested
- ABT 510
- Keywords
- Patients who have newly diagnosed brain tumors
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT 510Drug
ABT 510 (TSP-1 mimetic peptide) is a parenterally available nonapeptide analog of the heptapeptide and is a potent inhibitor of angiogenesis. ABT 510 competes with TSP-1 for binding to endothelial cells, but the exact mechanism of anti-angiogenesis is unknown. ABT 510 is administered by SQ injection. The starting dose of ABT 510 will be 20mg once daily (QD) SQ. Doses will be escalated by approximately 50% increments in consecutive cohorts of 3-6 patients until maximum tolerated dose is achieved.
| Study group | Role | What they receive |
|---|---|---|
| ABT 510 | Experimental | The only arm will receive the ABT 510 following standard therapy with radiation and temozolomide chemotherapy concurrent. Receives: Drug: ABT 510 |
What is being measured
The primary outcome is the main question the study is designed to answer.
All patients enrolled in this study will be statistically characterized for baseline and disease characteristics using descriptive statistics for continuous measures.
The primary outcome for the study was safety and to define the MTD (max tolerated dose). Also, survival was to be measured but the study was not powered to statistically have significance for that measure.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startAug 2003
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Burt Nabors, MD, University of Alabama at Birmingham
- Investigators
- Louis B Nabors, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584883
- Sponsor's protocol ID
- UAB 0327
- Other IDs
- ABT510
- Status last verified
- Jun 2023
- First submitted
- 26 Dec 2007
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of ABT 510 and Concurrent Temozolomide and Radiotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00584883
- Acronym / sponsor ID
- UAB 0327
- Conditions
- Brain Tumor
- Keywords
- Patients who have newly diagnosed brain tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the maximum tolerated dose of ABT 510 when administered concurrent with radiation therapy for patients with newly diagnosed glioblastoma multiforme.
Detailed description
- To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme.
- To determine the duration of disease free survival and overall survival associated with this therapy.
- Evaluate thrombospondin 1 (TSP-1) and 2 (TSP-2) in tumor vs. corresponding normal tissue using quantitative real time Polymerase Chain Reaction (Q-RT-PCR).
- Determine the effect of ABT 510 on tumor permeability and tumor blood volume as measured by non-invasive Magnetic Resonance Imaging (MRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABT 510 | Experimental | Drug: ABT 510The only arm will receive the ABT 510 following standard therapy with radiation and temozolomide chemotherapy concurrent. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be 19 years of age or older.
- Patients must have histologically proven newly diagnosed glioblastoma multiforme.
- Patients must have fully recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen for 5 days prior to entry.
- Patients must have a Karnofsky performance status > 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
- Patients must have adequate hematologic, renal and liver function (i.e. Absolute neutrophil count > 1500/mm3, Platelets > 100,000/mm3, creatinine 1.5 mg/dl .
Key exclusion criteria (11 listed)
- Pregnant or breast feeding.
- Prior therapy for the brain tumor (except surgery)
- Prior treatment with antineoplastic agents.
- Exclude sexually active males and females unwilling to practice contraception during the study.
- Serious concurrent infections.
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 |
|---|---|---|
| ABT 510ABT 510 (TSP-1 mimetic peptide) is a parenterally available nonapeptide analog of the heptapeptide and is a potent inhibitor of angiogenesis. ABT 510 competes with TSP-1 for binding to endothelial cells, but the exact mechanism of anti-angiogenesis is unknown. ABT 510 is administered by SQ injection. The starting dose of ABT 510 will be 20mg once daily (QD) SQ. Doses will be escalated by approximately 50% increments in consecutive cohorts of 3-6 patients until maximum tolerated dose is achieved. | Drug | ABT 510 |
Primary outcome
All patients enrolled in this study will be statistically characterized for baseline and disease characteristics using descriptive statistics for continuous measures.
Time frame: up to 2 years
The primary outcome for the study was safety and to define the MTD (max tolerated dose). Also, survival was to be measured but the study was not powered to statistically have significance for that measure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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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.
Louis B Nabors, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT 510 in people with Brain Tumor, run by University of Alabama at Birmingham 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 7 Jun 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All patients enrolled in this study will be statistically characterized for baseline and disease characteristics using descriptive statistics for continuous measures. (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?
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 7 Jun 2023.