Brain and Central Nervous System TumorsPhase 1/2NCT00009854
Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
A Phase 1/2 study testing carmustine in ethanol and conventional surgery in people with Brain and Central Nervous System Tumors and Metastatic Cancer, run by Direct Therapeutics at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of carmustine followed by surgery in treating patients who have recurrent supratentorial malignant glioma or metastatic brain neoplasm. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Metastatic Cancer
- What is being tested?
- carmustine in ethanol and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Jun 2000to not given
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed recurrent supratentorial malignant glioma with clear evidence of progression by MRI
- Glioblastoma multiforme
- Anaplastic ependymoma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma OR
- Metastatic tumor to the brain other than melanoma
- Planned resection of tumor (must be first surgery for recurrent disease)
- Tumor volume of each tumor component or residual tumor must be at least 4 cm3 and no greater than 33.4 cm3
- Tumor shape and surrounding structure(s) unlikely to cause an irregular distribution of the injected study drug
- Tumor is spherical, spheroid, or ovoid
- No tumors shaped into 3 or more components (e.g., multicentric or multilobulated)
- No tumors extending into the ventricular system
- Tumor has an intact stroma (i.e., tumor mass not partially incised or punctured)
- Central necrosis and/or central cystic areas allowed if an enhancing rim with a thickness of more than 5 mm is present
- No tumors in the following locations of the brain:
- Brainstem (pons or medulla)
- Midbrain (mesencephalon)
- Primary sensorimotor cortex in the dominant hemisphere
- Within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No evidence of bleeding diathesis
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT and SGPT no greater than 2.5 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 40 mL/min OR
- BUN no greater than 30 mg/dL
Other:
- No active uncontrolled infection
- Afebrile (37.5 degrees C) unless fever due to tumor
- No other unstable or severe medical condition
- No complicating medical or psychiatric problem that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas, mitomycin, or Gliadel wafers) and recovered
- No anti-tumor chemotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
- No prior intracranial brachytherapy
- No anti-tumor radiotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI
Surgery:
- See Disease Characteristics
- Prior surgery allowed
- No anti-tumor surgery within 12 weeks after study drug
Other:
- No concurrent anticoagulants
- No other concurrent investigational agents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massey Cancer Center
Richmond, Virginia, 23298-0631
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
About this study
Official title: Phase I/II Study of Intratumoral Injection of DTI-015 Prior to Tumor Resection in Patients With Recurrent Malignant Glioma or Metastatic Neoplasm to Brain
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of carmustine followed by surgery in treating patients who have recurrent supratentorial malignant glioma or metastatic brain neoplasm.
Read the detailed description
OBJECTIVES:
- Determine the extent and pattern of distribution of DNA adducts in patients with recurrent supratentorial malignant glioma or metastatic neoplasm to the brain treated with neoadjuvant intratumoral carmustine in ethanol (DTI-015) followed by tumor resection.
- Determine the qualitative and quantitative toxicity of this treatment regimen in these patients.
OUTLINE: This is a dose escalation study.
Patients receive neoadjuvant carmustine in ethanol (DTI-015) intratumorally under stereotactic guidance 45-90 minutes prior to craniotomy and tumor resection.
Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 3 or 3 of 6 patients experience dose-limiting toxicity.
Patients are followed at 4, 8, and 12 weeks, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
- Being tested
- carmustine in ethanol, conventional surgery
- Keywords
- adult glioblastoma, tumors metastatic to brain, adult anaplastic astrocytoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Neoplasm Metastasis, Glioblastoma, Brain Neoplasms, Astrocytoma, Ependymoma, Oligodendroglioma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carmustine in ethanolDrug
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- Direct Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gene David Resnick, MD, Study chair, Millennix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009854
- Sponsor's protocol ID
- CDR0000068416
- Other IDs
- DTI-0002, UCSF-H7858-17520-01, NCI-V00-1642
- Status last verified
- Mar 2003
- First submitted
- 2 Feb 2001
- Last updated
- 6 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Intratumoral Injection of DTI-015 Prior to Tumor Resection in Patients With Recurrent Malignant Glioma or Metastatic Neoplasm to Brain
- ClinicalTrials.gov ID
- NCT00009854
- Acronym / sponsor ID
- CDR0000068416
- Keywords
- adult glioblastoma, tumors metastatic to brain, adult anaplastic astrocytoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Direct TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2000
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of carmustine followed by surgery in treating patients who have recurrent supratentorial malignant glioma or metastatic brain neoplasm.
Detailed description
OBJECTIVES:
- Determine the extent and pattern of distribution of DNA adducts in patients with recurrent supratentorial malignant glioma or metastatic neoplasm to the brain treated with neoadjuvant intratumoral carmustine in ethanol (DTI-015) followed by tumor resection.
- Determine the qualitative and quantitative toxicity of this treatment regimen in these patients.
OUTLINE: This is a dose escalation study.
Patients receive neoadjuvant carmustine in ethanol (DTI-015) intratumorally under stereotactic guidance 45-90 minutes prior to craniotomy and tumor resection.
Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 3 or 3 of 6 patients experience dose-limiting toxicity.
Patients are followed at 4, 8, and 12 weeks, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| carmustine in ethanol | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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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.
Gene David Resnick, MD study chair
Millennix
2 sites 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 carmustine in ethanol and conventional surgery in people with Brain and Central Nervous System Tumors and Metastatic Cancer, run by Direct Therapeutics at 2 sites 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?
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: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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.
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 6 Nov 2013.