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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

France1 site
  • CHU Pitie-Salpetriere

    Paris, 75651

Other trials in France

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.

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.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 2001
  3. Primary completionOct 2003

Resources

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
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

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.

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