Brain and Central Nervous System TumorsPhase 2NCT00004204
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
A Phase 2 study testing temozolomide in people with Brain and Central Nervous System Tumors, run by Herbert Irving Comprehensive Cancer Center at 10 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 II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive 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?
- temozolomide
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Feb 2000to not given
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven recurrent or progressive malignant glioma of one of the following types:
- Anaplastic oligodendroglioma or oligoastrocytoma
- Anaplastic astrocytoma
- Glioblastoma multiforme (stratum closed to accrual 11/30/01)
- Patients who have failed radiotherapy are eligible
- Measurable disease by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10 g/dL
Hepatic:
- SGOT or SGPT less than 3 times upper limit of normal (ULN)
- Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed)
Renal:
- BUN less than 1.5 times ULN
- Creatinine less than 1.5 times ULN
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No other serious concurrent infection or other medical illness that would preclude study entry
- No frequent vomiting or partial bowel obstruction
- HIV negative
- No AIDS-related illness
- No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent epoetin alfa
Chemotherapy:
- At least 6 weeks since other prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator)
Surgery:
- Recovered from prior surgery
Other:
- No other concurrent investigational agents
- Concurrent anticonvulsant therapy allowed
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Cancer Center of Albany Medical Center
Albany, New York, 12208
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Neurological Clinic
Portland, Oregon, 97210
Stanford University Medical Center
Stanford, California, 94305-5408
Nalitt Institute for Cancer And Blood Related Diseases
Staten Island, New York, 10305
About this study
Official title: A Phase II Study of Temozolomide 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 II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive malignant glioma.
Read the detailed description
OBJECTIVES:
- Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.
- Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).
Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- temozolomide
- Keywords
- recurrent adult brain tumor, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2003 (estimated)
- Study startFeb 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Herbert Irving Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Casilda Balmaceda, MD, Study chair, Herbert Irving Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004204
- Sponsor's protocol ID
- CDR0000067449
- Other IDs
- CPMC-IRB-8622, SPRI-CPMC-IRB-8622
- Status last verified
- Apr 2006
- First submitted
- 21 Jan 2000
- Last updated
- 6 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas
- ClinicalTrials.gov ID
- NCT00004204
- Acronym / sponsor ID
- CDR0000067449
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Herbert Irving Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Feb 2000
- First posted
- 18 Jul 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 II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive malignant glioma.
Detailed description
OBJECTIVES:
- Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.
- Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).
Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
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 |
|---|---|---|
| temozolomide | Drug | – |
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 Jan 2014.
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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.
Casilda Balmaceda, MD study chair
Herbert Irving Comprehensive Cancer Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing temozolomide in people with Brain and Central Nervous System Tumors, run by Herbert Irving Comprehensive Cancer Center at 10 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 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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 Jan 2014.