Brain and Central Nervous System TumorsPhase 2NCT00002814
Combination Chemotherapy for Patients With Brain Cancer
A Phase 2 study testing filgrastim, paclitaxel and topotecan hydrochloride in people with Brain and Central Nervous System Tumors, run by Dartmouth-Hitchcock Medical Center 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy using paclitaxel and topotecan, plus G-CSF, in treating patients… 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?
- filgrastim, paclitaxel and topotecan hydrochloride
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1996to Dec 2001
- 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: Biopsy proven glioblastoma multiforme or anaplastic astrocytoma Central pathologic review at Dartmouth-Hitchcock Medical Center, including assay for tumor p53 expression No anaplastic oligodendroglioma No mixed oligodendroastrocytoma Recurrent or progressive disease following radiotherapy documented by CT or MRI within 2 weeks of entry
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 3,000 ANC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.0 mg/dL AST/ALT no greater than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: No documented sensitivity to E. coli-derived products No major medical or psychiatric illness that would interfere with therapy or compliance with scheduled follow-up No pregnant or nursing women Adequate contraception required of fertile patients
PRIOR CONCURRENT THERAPY: No prior taxanes or topoisomerase I inhibitors At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) At least 4 weeks since radiotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Phase II Trial of Paclitaxel and Topotecan With Filgrastim in Patients With Recurrent or Refractory Glioblastoma Multiforme or Anaplastic Astrocytoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy using paclitaxel and topotecan, plus G-CSF, in treating patients with glioblastoma multiforme or anaplastic astrocytoma that is refractory or recurrent.
Read the detailed description
OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent glioblastoma multiforme or anaplastic astrocytoma treated with paclitaxel (TAX) and topotecan (TOPO) with granulocyte colony-stimulating factor (G-CSF) support. II. Determine survival in these patients. III. Describe the toxicity of TAX/TOPO/G-CSF. IV. Evaluate tumor p53 expression in relation to response to TAX/TOPO/G-CSF.
OUTLINE: All patients receive paclitaxel, topotecan, and G-CSF every 3 weeks for at least 2 courses and until 2 courses beyond maximum response. Patients are followed every 3 months for 2 years, then every 6 months for relapse and survival.
PROJECTED ACCRUAL: A total of 35 patients will be entered if there are 1-3 responses in the first 20 patients.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- filgrastim, paclitaxel, topotecan hydrochloride
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
paclitaxelDrug
topotecan hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2004 (estimated)
- Study startAug 1996
- Primary completionApr 2001
- Study completionDec 2001
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 Dartmouth-Hitchcock Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camilo E Fadul, MD, Study chair, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002814
- Sponsor's protocol ID
- D9607
- Other IDs
- NCI-V96-0955
- Status last verified
- Oct 2011
- First submitted
- 1 Nov 1999
- Last updated
- 27 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Paclitaxel and Topotecan With Filgrastim in Patients With Recurrent or Refractory Glioblastoma Multiforme or Anaplastic Astrocytoma
- ClinicalTrials.gov ID
- NCT00002814
- Acronym / sponsor ID
- D9607
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Aug 1996
- Primary completion
- Apr 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 6 Apr 2004 (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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy using paclitaxel and topotecan, plus G-CSF, in treating patients with glioblastoma multiforme or anaplastic astrocytoma that is refractory or recurrent.
Detailed description
OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent glioblastoma multiforme or anaplastic astrocytoma treated with paclitaxel (TAX) and topotecan (TOPO) with granulocyte colony-stimulating factor (G-CSF) support. II. Determine survival in these patients. III. Describe the toxicity of TAX/TOPO/G-CSF. IV. Evaluate tumor p53 expression in relation to response to TAX/TOPO/G-CSF.
OUTLINE: All patients receive paclitaxel, topotecan, and G-CSF every 3 weeks for at least 2 courses and until 2 courses beyond maximum response. Patients are followed every 3 months for 2 years, then every 6 months for relapse and survival.
PROJECTED ACCRUAL: A total of 35 patients will be entered if there are 1-3 responses in the first 20 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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 |
|---|---|---|
| filgrastim | Biological | – |
| paclitaxel | Drug | – |
| topotecan hydrochloride | 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 27 Oct 2011.
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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.
Camilo E Fadul, MD study chair
Dartmouth-Hitchcock Medical Center
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, paclitaxel and topotecan hydrochloride in people with Brain and Central Nervous System Tumors, run by Dartmouth-Hitchcock Medical 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?
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 27 Oct 2011. 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 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 27 Oct 2011.