GliomaPhase 1/2NCT00038441
Phase I Trial of Intramural Injection of DTI-015 for Recurrent Malignant Gliomas
A Phase 1/2 study testing DTI-015 in people with Glioma and Brain Neoplasms, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This is a clinical research study of a new investigational treatment for cancer called "DTI-015" to be given by intratumoral injection. Intratumoral injection is when drug is injected directly into the tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioma, Brain Neoplasms
- What is being tested?
- DTI-015
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1995to Aug 2005
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic proof of recurrent previously irradiated supratentorial malignant gliomas including anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma, or anaplastic ependymoma.
- It must be judged that gross total resection of the patient's tumor is not possible or the patient must refuse open resection of tumor. The decision that the tumor cannot be totally resected will be made by and mutually agreed upon by the physician investigators in the study.
- There must be a tumor volume of each tumor component greater than or equal to 0.5 and less than or equal to 15 cubic centimeters.
- The patient must be undergoing a stereotactic biopsy for other clinical reasons than the injection of DTI-015.
- The patient must have a Karnofsky functional status rating greater than or equal to 60.
- The patient must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy.
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- The patient must be able to read and fully understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital.
- The patient must be willing and able to comply with the protocol.
- For a female patient of childbearing potential, the patient must not be pregnant as evidenced by a menses in the last 8 weeks or by a negative urine HCG pregnancy test.
Who cannot join
- Any radiotherapy or chemotherapy during four weeks prior to entering the study.
- Nitrosoureas or mitomycin C during six weeks prior to entering the study.
- Patients with active uncontrolled infection.
- Serious liver or bone marrow disorder - specifically serum bilirubin >2.0 mg%, SGOT >2.5 times normal, SGPT >2.5 times normal, absolute neutrophil count <1500/mm3, platelet count <100,000/mm3.
- Evidence of renal failure (blood creatinine >2.0 mg%, BUN >30 mg/dl or creatinine clearance >40 ml/min
- Evidence of a bleeding diathesis or use of anticoagulant medications.
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- Unstable or severe intercurrent medical conditions.
- For females: risk of pregnancy (i.e., unwillingness to use adequate protection to prevent pregnancy), breast feeding a baby during the study period, or lactation.
- Tumors shaped into 3 or more components are excluded. Ovoid-shaped or spherical tumors are allowed. Central necrosis and/or central cystic areas are allowed as long as there is an enhancing rim with a thickness >5 mm.
- Patients who have undergone a partial resection of tumor and who have a cavity inside the residual tumor are excluded.
- Patients with tumors located in the following areas of the brain will be excluded: brainstem (pons or medulla), midbrain (mesencephalon), primary sensorimotor cortex in the dominant hemisphere, or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve.
- Patients with tumors extending into the ventricular system will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Trial of Intratumoral Injection of DTI-015 for Recurrent Malignant Gliomas
This is a clinical research study of a new investigational treatment for cancer called "DTI-015" to be given by intratumoral injection. Intratumoral injection is when drug is injected directly into the tumor. This study will help doctors find out what is the best dose level for DTI-015 and if this treatment can shrink tumors without causing severe side effects. The effects of the drug on the patient's quality of life (how the patient feels and what the patient can do) and their mental functions (reasoning and thinking abilities) will also be studied.
Read the detailed description
This study will involve 45 patients with malignant glioma brain tumors. Before the study, all patients will be given a physical exam and blood and urine tests, and they will be asked about their cancer and treatment. A magnetic resonance imaging (MRI) scan of the brain will pinpoint the location of the tumor. Female patients who are able to have children will have a pregnancy test. All patients will be asked about their quality of life and will undergo tests of their mental functions. Patients might receive a steroid drug for several days before and after the treatment. This will help prevent swelling around the tumor. Patients will also be given a drug to prevent convulsions.
DTI-015 will be injected through a catheter (a hollow tube) into the center of the brain tumor. For patients undergoing a needle biopsy, computer ("stereotactic") guidance will be used to place the catheter. For patients undergoing an open brain operation, the catheter will be placed under the direct vision of the surgeon or with computer guidance. It is possible that the injection might not be done in the brain operation patients because there either is too much or too little tumor after the resection. The catheter will be removed after the injection.
Each patient will receive only one injection although one of the first three patients might receive a second injection if the first injection volume was less than 25% of the tumor volume. A second injection can also be given to those patients who were stable after the first injection and develop a nodule of growth. If >250 mg BCNU total was injected, any repeat injection cannot be done for at least 6 weeks. The dose of DTI-015 will depend on the size of the patient's tumor. The dose level will be increased after the first 3 patients and again after the next 3 patients. After the treatment, the patient will remain in the hospital for 1 day.
Several tests will be repeated during the study. Patients will come to M.D. Anderson every 2-4 weeks for a total of 12 weeks. Blood tests will be done during each visit. An MRI scan of the brain will be done every month for 3 months. The physical exam, quality of life questionnaire, and mental functions tests will be repeated 12 weeks after the treatment. Some blood tests, however, may be done by a local doctor. The test results would then be sent to the study coordinator. The follow-up visits will end after 12 weeks.
- Conditions
- Glioma, Brain Neoplasms
- Being tested
- DTI-015
- Keywords
- Malignant Glioma
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTI-015Drug
DTI-015 injected through a catheter into center of brain tumor.
| Study group | Role | What they receive |
|---|---|---|
| DTI-015 | Experimental | Not described Receives: Drug: DTI-015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Dose of DTI-015
Measured: Every 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2002 (estimated)
- Study startSep 1995
- Primary completionFeb 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Direct Therapeutics
- Responsible party
- Sponsor
- Investigators
- Samuel J. Hassenbusch, MD, PHD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038441
- Sponsor's protocol ID
- ID95-115
- Status last verified
- Oct 2018
- First submitted
- 30 May 2002
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Intratumoral Injection of DTI-015 for Recurrent Malignant Gliomas
- ClinicalTrials.gov ID
- NCT00038441
- Acronym / sponsor ID
- ID95-115
- Conditions
- Glioma, Brain Neoplasms
- Keywords
- Malignant Glioma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Direct Therapeutics
- Study start
- Sep 1995
- Primary completion
- Feb 2003 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 31 May 2002 (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.
This is a clinical research study of a new investigational treatment for cancer called "DTI-015" to be given by intratumoral injection. Intratumoral injection is when drug is injected directly into the tumor. This study will help doctors find out what is the best dose level for DTI-015 and if this treatment can shrink tumors without causing severe side effects. The effects of the drug on the patient's quality of life (how the patient feels and what the patient can do) and their mental functions (reasoning and thinking abilities) will also be studied.
Detailed description
This study will involve 45 patients with malignant glioma brain tumors. Before the study, all patients will be given a physical exam and blood and urine tests, and they will be asked about their cancer and treatment. A magnetic resonance imaging (MRI) scan of the brain will pinpoint the location of the tumor. Female patients who are able to have children will have a pregnancy test. All patients will be asked about their quality of life and will undergo tests of their mental functions. Patients might receive a steroid drug for several days before and after the treatment. This will help prevent swelling around the tumor. Patients will also be given a drug to prevent convulsions.
DTI-015 will be injected through a catheter (a hollow tube) into the center of the brain tumor. For patients undergoing a needle biopsy, computer ("stereotactic") guidance will be used to place the catheter. For patients undergoing an open brain operation, the catheter will be placed under the direct vision of the surgeon or with computer guidance. It is possible that the injection might not be done in the brain operation patients because there either is too much or too little tumor after the resection. The catheter will be removed after the injection.
Each patient will receive only one injection although one of the first three patients might receive a second injection if the first injection volume was less than 25% of the tumor volume. A second injection can also be given to those patients who were stable after the first injection and develop a nodule of growth. If >250 mg BCNU total was injected, any repeat injection cannot be done for at least 6 weeks. The dose of DTI-015 will depend on the size of the patient's tumor. The dose level will be increased after the first 3 patients and again after the next 3 patients. After the treatment, the patient will remain in the hospital for 1 day.
Several tests will be repeated during the study. Patients will come to M.D. Anderson every 2-4 weeks for a total of 12 weeks. Blood tests will be done during each visit. An MRI scan of the brain will be done every month for 3 months. The physical exam, quality of life questionnaire, and mental functions tests will be repeated 12 weeks after the treatment. Some blood tests, however, may be done by a local doctor. The test results would then be sent to the study coordinator. The follow-up visits will end after 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DTI-015 | Experimental | Drug: DTI-015 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologic proof of recurrent previously irradiated supratentorial malignant gliomas including anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma, or anaplastic ependymoma.
- It must be judged that gross total resection of the patient's tumor is not possible or the patient must refuse open resection of tumor. The decision that the tumor cannot be totally resected will be made by and mutually agreed upon by the physician investigators in the study.
- There must be a tumor volume of each tumor component greater than or equal to 0.5 and less than or equal to 15 cubic centimeters.
- The patient must be undergoing a stereotactic biopsy for other clinical reasons than the injection of DTI-015.
- The patient must have a Karnofsky functional status rating greater than or equal to 60.
Key exclusion criteria (12 listed)
- Any radiotherapy or chemotherapy during four weeks prior to entering the study.
- Nitrosoureas or mitomycin C during six weeks prior to entering the study.
- Patients with active uncontrolled infection.
- Serious liver or bone marrow disorder - specifically serum bilirubin >2.0 mg%, SGOT >2.5 times normal, SGPT >2.5 times normal, absolute neutrophil count <1500/mm3, platelet count <100,000/mm3.
- Evidence of renal failure (blood creatinine >2.0 mg%, BUN >30 mg/dl or creatinine clearance >40 ml/min
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 |
|---|---|---|
| DTI-015DTI-015 injected through a catheter into center of brain tumor. | Drug | DTI-015 |
Primary outcome
Maximum Dose of DTI-015
Time frame: Every 2-4 weeks
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 31 Oct 2018.
- UT MD Anderson Cancer Center 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.
Samuel J. Hassenbusch, MD, PHD principal investigator
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 1/2 study testing DTI-015 in people with Glioma and Brain Neoplasms, 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 9 inclusion and 12 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 31 Oct 2018. 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 combined 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.
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?
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?
Maximum Dose of DTI-015 (time frame: Every 2-4 weeks). 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 2018.