Brain and Central Nervous System TumorsPhase 2NCT00006263
Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
A Phase 2 study testing filgrastim, carboplatin and temozolomide in people with Brain and Central Nervous System Tumors, run by NYU Langone Health at 1 site 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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of… Read more about this study
- Who is it for?
- Ages Up to 64 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- filgrastim, carboplatin and temozolomide
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to 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 Up to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed glioblastoma multiforme or anaplastic astrocytoma
- Residual tumor on postoperative MRI
- Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
- Under 65
Performance status:
- Karnofsky or Lansky 70-100% OR
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3
- Hemoglobin at least 8 g/dL (transfusion allowed)
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGPT no greater than 3 times ULN
Renal:
- Age 5 years and under: Creatinine less than 1.2 mg/dL
- Age over 5 to 10 years: Creatinine less than 1.5 mg/dL
- Age over 10 to 15 years: Creatinine less than 1.8 mg/dL
- Age over 15 years: Creatinine less than 2.4 mg/dL
Cardiovascular:
- No myocardial infarction within the past 6 months
Other:
- No other concurrent serious medical condition that would preclude study
- Able to tolerate oral medications
- No prior malignancy for which patient received prior chemotherapy or spinal irradiation
- No history of severe allergic reaction to platinum-containing compounds
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 72 hours since prior filgrastim (G-CSF)
Chemotherapy:
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- Concurrent steroids for tumor-related cerebral edema allowed
- No concurrent corticosteroids for solely antiemetic purposes
Radiotherapy:
- No prior or concurrent radiotherapy
Surgery:
- Recovered from prior surgery
- No concurrent surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
About this study
Official title: Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide, and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma.
Read the detailed description
OBJECTIVES:
- Determine the response rate in patients with newly diagnosed high-grade glioma treated with temozolomide, carboplatin, and filgrastim (G-CSF).
- Determine the toxicity of this treatment regimen in these patients.
- Determine the rate of tumor progression in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to disease category (glioblastoma multiforme vs anaplastic astrocytoma vs several other high-grade mixed gliomas).
Patients receive carboplatin IV over 4 hours on days 1-2; oral temozolomide every 12 hours on days 1-5; and filgrastim (G-CSF) subcutaneously or IV daily starting no earlier than day 7 and continuing until blood counts recover. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 102-222 (17-37 per each of 6 strata) will be accrued for this study within 4 years.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- filgrastim, carboplatin, temozolomide
- Keywords
- adult brain stem glioma, adult glioblastoma, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Glioblastoma, Astrocytoma, Oligodendroglioma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
carboplatinDrug
temozolomideDrug
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 startNov 1997
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 NYU Langone HealthThe 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 2
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jonathan L. Finlay, MB, ChB, Study chair, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006263
- Sponsor's protocol ID
- CDR0000068203
- Other IDs
- NYU-0004H, NYU-0029H, NCI-G00-1856
- Status last verified
- Aug 2015
- First submitted
- 11 Sep 2000
- Last updated
- 5 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent
- ClinicalTrials.gov ID
- NCT00006263
- Acronym / sponsor ID
- CDR0000068203
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult brain stem glioma, adult glioblastoma, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 1997
- 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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide, and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma.
Detailed description
OBJECTIVES:
- Determine the response rate in patients with newly diagnosed high-grade glioma treated with temozolomide, carboplatin, and filgrastim (G-CSF).
- Determine the toxicity of this treatment regimen in these patients.
- Determine the rate of tumor progression in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to disease category (glioblastoma multiforme vs anaplastic astrocytoma vs several other high-grade mixed gliomas).
Patients receive carboplatin IV over 4 hours on days 1-2; oral temozolomide every 12 hours on days 1-5; and filgrastim (G-CSF) subcutaneously or IV daily starting no earlier than day 7 and continuing until blood counts recover. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 102-222 (17-37 per each of 6 strata) will be accrued for this study within 4 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| filgrastim | Biological | – |
| carboplatin | Drug | – |
| temozolomide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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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.
Jonathan L. Finlay, MB, ChB study chair
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, carboplatin and temozolomide in people with Brain and Central Nervous System Tumors, run by NYU Langone Health 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?
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: withdrawn, as of the sponsor's last update on 5 Aug 2015. 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 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 was withdrawn before enrolling participants, so there are no results.
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 5 Aug 2015.