Brain and Central Nervous System TumorsPhase 1NCT00025311
Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain
A Phase 1 study testing topotecan hydrochloride in people with Brain and Central Nervous System Tumors, run by NYU Langone Health at 3 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the lining around the… Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- topotecan hydrochloride
- How many people
- Not given
- Where
- 3 sitesin 2 countries
- Study dates
- May 2001to Oct 2003
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologic or tumor marker confirmation of malignancy at original diagnosis
- Neoplastic meningitis/leptomeningeal metastasis refractory to conventional therapy and other therapies of higher priority, defined as:
- Stratum A:
- Small non-cleaved lymphoma (Burkitt's) with any L-3 blast in cerebrospinal fluid (CSF)
- Any other lymphoma or leukemia with CSF cell count greater than 5/mm3 AND evidence of blast cells by cytology or cytospin preparation OR
- Stratum B:
- Solid tumor or other malignancy with presence of tumor cells on cytospin OR positive cytology OR neuroimaging evidence of leptomeningeal tumor by MRI or CT myelogram
- No leptomeningeal leukemia or lymphoma with concurrent bone marrow relapse
- No clinical evidence of untreated obstructive hydrocephalus or compartmentalization of the CSF
PATIENT CHARACTERISTICS:
Age:
- 65 and under
Performance status:
- Lansky 50-100% (age 16 and under)
- Karnofsky 50-100% OR ECOG 0-3 (over age 16)
Life expectancy:
- At least 2 months
Hematopoietic:
- Stratum B:
- Absolute neutrophil count at least 750/mm^3
- Platelet count at least 75,000/mm^3 (transfusion independent)
- Hemoglobin at least 10.0 g/dL (red blood cell transfusions allowed)
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT or SGPT less than 2.5 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Neurologic:
- Seizures allowed if well controlled and on anticonvulsants
- CNS toxicity no greater than grade 2
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infections
- HIV allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunomodulating agents (stratum B)
- No stem cell transplantation (stratum A)
Chemotherapy:
- At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas)
- No other concurrent cancer chemotherapy (stratum B)
- Other concurrent systemic cancer chemotherapy for leukemia or lymphoma allowed with the following restrictions:
- No oral or IV topotecan
- No moderate or high-dose IV or subcutaneous cytarabine (greater than 1.0 g/m2 per day)
- No moderate or high-dose IV methotrexate (greater than 1 g/m2 per day)
- No IV thiotepa
- No myeloablative chemotherapy
- No intrathecal or intraventricular chemotherapy
Endocrine therapy:
- Concurrent corticosteroids allowed only for treatment of increased intracranial pressure in patients with CNS tumors
- No concurrent intrathecal or intraventricular hydrocortisone
Radiotherapy:
- At least 4 weeks since completion of radiotherapy to the brain or spine and recovered
- Concurrent radiotherapy to localized painful lesions producing acute neurologic dysfunction allowed provided at least 1 measurable lesion is not irradiated
- No concurrent craniospinal or whole-brain radiotherapy
Surgery:
- Not specified
Other:
- Recovered from prior therapy
- At least 7 days since prior investigational drug
- No other concurrent intrathecal or intraventricular therapy for leptomeningeal disease
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
About this study
Official title: A Phase I Study Of Seven Day Continuous Intrathecal/Intraventricular Infusion Of Topotecan For Patients With Recurrent, Progressive Or Refractory Leptomingeal Disease
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the lining around the brain.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of intrathecal or intraventricular topotecan in patients with recurrent, progressive, or refractory leptomeningeal disease.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the anti-tumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to disease (leukemia or lymphoma vs solid tumor or other malignancy).
Patients receive topotecan intrathecally or intraventricularly continuously on days 1-7. Treatment repeats every 21 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose- limiting toxicity.
Patients are followed for 6 months.
PROJECTED ACCRUAL: A maximum of 50 patients (25 per stratum) will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- topotecan hydrochloride
- Keywords
- leptomeningeal metastases
- Medical subject headings
- Central Nervous System Neoplasms, Meningeal Carcinomatosis
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 posted27 Jan 2003 (estimated)
- Study startMay 2001
- Primary completionOct 2003
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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jonathan L. Finlay, MB, ChB, Study chair, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025311
- Sponsor's protocol ID
- CDR0000068949
- Other IDs
- NYU-0005H, NYU-0041H, NCI-G01-2018
- Status last verified
- Mar 2003
- First submitted
- 11 Oct 2001
- Last updated
- 9 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Of Seven Day Continuous Intrathecal/Intraventricular Infusion Of Topotecan For Patients With Recurrent, Progressive Or Refractory Leptomingeal Disease
- ClinicalTrials.gov ID
- NCT00025311
- Acronym / sponsor ID
- CDR0000068949
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- leptomeningeal metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2001
- Primary completion
- Oct 2003 (actual)
- 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 cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the lining around the brain.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of intrathecal or intraventricular topotecan in patients with recurrent, progressive, or refractory leptomeningeal disease.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the anti-tumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to disease (leukemia or lymphoma vs solid tumor or other malignancy).
Patients receive topotecan intrathecally or intraventricularly continuously on days 1-7. Treatment repeats every 21 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose- limiting toxicity.
Patients are followed for 6 months.
PROJECTED ACCRUAL: A maximum of 50 patients (25 per stratum) will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 9 Nov 2012.
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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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing topotecan hydrochloride in people with Brain and Central Nervous System Tumors, run by NYU Langone Health at 3 sites in 2 countries.
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 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, France. 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 9 Nov 2012.