Brain and Central Nervous System TumorsPhase 2NCT00003372
Topotecan in Treating Patients With Recurrent Brain Tumors
A Phase 2 study testing topotecan hydrochloride in people with Brain and Central Nervous System Tumors, run by NCIC Clinical Trials Group at 11 sites in Canada.
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 topotecan in treating patients with recurrent brain tumor. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- topotecan hydrochloride
- How many people
- 17 participants
- Where
- 11 sitesCanada
- Study dates
- 8 Dec 1997to 21 Dec 2009
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven recurrent anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma following primary surgery and radiation therapy Tumors for anaplastic mixed oligoastrocytoma must contain at least 25% oligodendroglial elements Tumors must be clinically aggressive for patients with only 1 anaplastic feature Prior low grade oligodendrogliomas or oligoastrocytomas undergoing repeat biopsy following clinical or radiological progression are eligible Bidimensionally measurable and progressive lesions by CT or MRI
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine normal Other: Not pregnant or nursing Fertile patients must use effective contraception No prior malignancies except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer No other serious illness or medical condition No active uncontrolled infection No history of neurologic or psychiatric disorder
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since chemotherapy No more than 1 prior chemotherapy regimen No prior camptothecin derivatives Endocrine therapy: At least 2 weeks on stable steroid therapy, if necessary Radiotherapy: At least 2 months since prior radiotherapy No prior radiation therapy for recurrent disease Surgery: At least 6 weeks since prior surgery (except biopsy only) Prior surgery for recurrent disease allowed (including stereotactic biopsy or partial resection) Other: No concurrent experimental drugs or anticancer therapy
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6
Ottawa Regional Cancer Centre - Civic Campus
Ottawa, Ontario, K1Y 4K7
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: A Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma
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 topotecan in treating patients with recurrent brain tumor.
Read the detailed description
OBJECTIVES: I. Determine the efficacy of topotecan in patients with recurrent anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma. II. Determine the qualitative and quantitative toxicity of topotecan in this patient population on this schedule.
OUTLINE: This is a multicenter study. Patients receive intravenous topotecan over 30 minutes daily for 5 days every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients will be followed every 3 months until death.
PROJECTED ACCRUAL: Up to 30 evaluable patients will be accrued within 2-3 years.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- topotecan hydrochloride
- Keywords
- recurrent adult brain tumor, adult anaplastic oligodendroglioma, adult mixed glioma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Oligodendroglioma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topotecan hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2004 (estimated)
- Study start8 Dec 1997
- Primary completion5 Oct 2000
- Study completion21 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Karl Belanger, MD, Study chair, CHUM - Hotel Dieu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003372
- Sponsor's protocol ID
- I109
- Other IDs
- CAN-NCIC-IND109, CDR0000066362
- Status last verified
- Apr 2020
- First submitted
- 1 Nov 1999
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belanger K, MacDonald D, Cairncross G, Gertler S, Forsyth P, Burdette-Radoux S, Bergeron J, Soulieres D, Ludwin S, Wainman N, Eisenhauer E. A phase II study of topotecan in patients with anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma. Invest New Drugs. 2003 Nov;21(4):473-80. doi: 10.1023/a:1026211620793.
PubMed 14586216
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma
- ClinicalTrials.gov ID
- NCT00003372
- Acronym / sponsor ID
- I109
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult anaplastic oligodendroglioma, adult mixed glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 8 Dec 1997 (actual)
- Primary completion
- 5 Oct 2000 (actual)
- Study completion
- 21 Dec 2009 (actual)
- First posted
- 9 Jun 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.
PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with recurrent brain tumor.
Detailed description
OBJECTIVES: I. Determine the efficacy of topotecan in patients with recurrent anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma. II. Determine the qualitative and quantitative toxicity of topotecan in this patient population on this schedule.
OUTLINE: This is a multicenter study. Patients receive intravenous topotecan over 30 minutes daily for 5 days every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients will be followed every 3 months until death.
PROJECTED ACCRUAL: Up to 30 evaluable patients will be accrued within 2-3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 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 |
|---|---|---|
| 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 8 Apr 2020.
- Results publication: PubMed 14586216Belanger K, MacDonald D, Cairncross G, Gertler S, Forsyth P, Burdette-Radoux S, Bergeron J, Soulieres D, Ludwin S, Wainman N, Eisenhauer E. A phase II study of topotecan in patients with anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma. Invest New Drugs. 2003 Nov;21(4):473-80. doi: 10.1023/a:1026211620793.
- Individual participant dataSharing planned: No
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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.
Karl Belanger, MD study chair
CHUM - Hotel Dieu Hospital
11 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 topotecan hydrochloride in people with Brain and Central Nervous System Tumors, run by NCIC Clinical Trials Group at 11 sites in Canada.
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 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada. 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?
On the ClinicalTrials.gov record for NCT00003372, which also lists 1 linked publication.
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 8 Apr 2020.