Brain and Central Nervous System TumorsPhase 1NCT00014521
Karenitecin in Treating Patients With Recurrent Malignant Glioma
A Phase 1 study testing karenitecin in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI) at 8 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 trial to study the effectiveness of karenitecin in treating patients who have recurrent malignant glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- karenitecin
- How many people
- Not given
- Where
- 8 sitesUnited States
- Study dates
- Jan 2002to not given
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme
- Progressive or recurrent disease previously treated with radiotherapy with or without chemotherapy
- Prior low-grade disease that progressed to high-grade after therapy allowed
- Measurable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
- 18 and over
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/mm3
- Hemoglobin at least 8.5 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- Transaminases no greater than 4 times upper limit of normal
Renal:
- Creatinine no greater than 1.7 mg/dL
Other:
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
- No serious concurrent infection
- No other medical illness that would preclude study
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No more than 1 prior chemotherapy regimen
Endocrine therapy:
- Must be on stable dose of steroids for at least 5 days
Radiotherapy:
- See Disease Characteristics
- At least 3 months since prior radiotherapy and recovered
- No more than 1 prior course of radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent investigational agents
- At least 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, 48202
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1030
About this study
Official title: Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of karenitecin in treating patients who have recurrent malignant glioma.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of karenitecin in patients with recurrent malignant glioma who are receiving or not receiving anticonvulsants known to be metabolized by the P450 hepatic enzyme complex.
- Determine the pharmacokinetics of this drug in these patients.
- Assess the preliminary evidence of therapeutic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to use of anticonvulsants known to be metabolized by the P450 hepatic enzyme complex (yes vs no).
Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of karenitecin according to the continual reassessment method until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose associated with a dose-limiting toxicity rate of 33%.
Patients are followed every 2 months.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study within 1 year.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- karenitecin
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Oligodendroglioma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
karenitecinDrug
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 startJan 2002
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.
- More trials run by National Cancer Institute (NCI)The 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
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Stuart A. Grossman, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014521
- Sponsor's protocol ID
- CDR0000068552
- Other IDs
- NABTT-2006, JHOC-NABTT-2006
- Status last verified
- Feb 2005
- First submitted
- 10 Apr 2001
- Last updated
- 24 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas
- ClinicalTrials.gov ID
- NCT00014521
- Acronym / sponsor ID
- CDR0000068552
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 2002
- 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 trial to study the effectiveness of karenitecin in treating patients who have recurrent malignant glioma.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of karenitecin in patients with recurrent malignant glioma who are receiving or not receiving anticonvulsants known to be metabolized by the P450 hepatic enzyme complex.
- Determine the pharmacokinetics of this drug in these patients.
- Assess the preliminary evidence of therapeutic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to use of anticonvulsants known to be metabolized by the P450 hepatic enzyme complex (yes vs no).
Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of karenitecin according to the continual reassessment method until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose associated with a dose-limiting toxicity rate of 33%.
Patients are followed every 2 months.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| karenitecin | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jul 2008.
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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.
Stuart A. Grossman, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing karenitecin in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI) at 8 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: finished, as of the sponsor's last update on 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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.
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 24 Jul 2008.