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AIDS-related Diffuse Large Cell LymphomaPhase 2NCT00005811

Topotecan Hydrochloride in Treating Children With Meningeal Cancer That Has Not Responded to Previous Treatment

A Phase 2 study testing topotecan hydrochloride and laboratory biomarker analysis in people with AIDS-related Diffuse Large Cell Lymphoma and AIDS-related Diffuse Mixed Cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

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

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well topotecan hydrochloride works in treating children with meningeal cancer that has not responded to previous treatment Read more about this study

Who is it for?
Ages 1 year to 21 years
What is being tested?
topotecan hydrochloride and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteUnited States
Study dates
Apr 2000to Feb 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 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Histologically proven refractory leukemia, lymphoma, or other solid tumor thathas overt meningeal involvement (Recurrent CNS acute lymphoblastic leukemia stratum only open to accrual as of 11/30/04)
  • Definition of meningeal disease:
  • Leukemia/lymphoma (including acute lymphoblastic leukemia)
  • CSF cell count greater than 5/mm^3 AND evidence of blast cells oncytospin preparation or by cytology
  • Refractory to conventional therapy, including radiotherapy (i.e., in second or greater relapse)
  • No concurrent bone marrow relapse
Show all 40Show fewer
  • Solid tumors (including medulloblastoma)
  • Presence of tumor cells on cytospin preparation or cytology OR presence ofmeningeal disease on MRI scans
  • No clinical evidence of obstructive hydrocephalus or compartmentalization ofCSF flow as documented by radioisotope indium In 111 or technetium Tc 99 DTPAflow study
  • If CSF flow block is demonstrated, focal radiotherapy must be administered tosite of block to restore flow and a repeat CSF flow study must show clearing of blockage
  • No ventriculoperitoneal or ventriculoatrial shunt unless:
  • Patient is shunt independent and there is evidence that the shunt is nonfunctional
  • CSF flow study demonstrates normal flow
  • No impending cord compression, CNS involvement requiring local radiotherapy(e.g., optic nerve), or isolated bulky ventricular or leptomeningeal basedlesions
  • Performance status - Lansky 50-100% (age 10 and under)
  • Performance status - Karnofsky 50-100% (over age 10)
  • At least 8 weeks
  • Platelet count greater than 40,000/mm^3 (transfusions allowed)
  • Bilirubin less than 2.0 mg/dL
  • SGPT less than 5 times normal
  • Creatinine less than 1.5 mg/dL
  • Electrolytes, calcium, and phosphorus normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant illness (e.g., uncontrolled infection, except HIV [i.e., AIDS-related lymphomatous meningitis])
  • Prior immunotherapy allowed and recovered
  • At least 3 weeks since systemic CNS directed chemotherapy (6 weeks for nitrosoureas) and recovered
  • At least 1 week since prior intrathecal (IT) chemotherapy (2 weeks for cytarabine [liposomal])
  • No prior IT chemotherapy on days -14 to -7 before study entry unless evidence of disease progression (e.g., increasing WBC and percentage blasts in patients with leukemia/lymphoma or increased leptomeningeal enhancements in patients with solid tumors) (Recurrent CNS acute lymphoblastic leukemia stratum only open to accrual as of 11/30/04)
  • Concurrent chemotherapy to control systemic disease or bulk CNS disease allowed if the systemic chemotherapy is not a phase I study agent that significantly penetrates the CSF (e.g., high-dose systemic methotrexate [greater than 1 g/m^2], thiotepa, high-dose cytarabine, temozolomide, IV mercaptopurine, nitrosourea, or topotecan) or an agent known to have serious unpredictable CNS side effects
  • Concurrent dexamethasone or prednisone allowed if part of a systemic chemotherapy regimen
  • See Disease Characteristics
  • At least 8 weeks since prior cranial irradiation and recovered
  • No concurrent whole brain or craniospinal irradiation
  • At least 7 days since prior investigational drug
  • Time period should be extended if patient has received any investigational agent that is known to have delayed toxic effects after 7 days or a prolonged half-life
  • No other concurrent investigational agents
  • No concurrent therapy (IT or systemic) for leptomeningeal disease
  • No other concurrent systemic agents that significantly penetrate the blood-brain barrier

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Oncology Group

    Arcadia, California, 91006-3776

Other trials in United States

About this study

Official title: A Phase II Study of Intrathecal Topotecan (NSC #609699) in Patients With Refractory Meningeal Malignancies

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well topotecan hydrochloride works in treating children with meningeal cancer that has not responded to previous treatment

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the therapeutic activity of intrathecal topotecan, in terms of response rate and time to central nervous system (CNS) progression, in pediatric patients with recurrent or refractory neoplastic meningitis.

II. Determine the safety and toxicity of this regimen in these patients. III. Evaluate the concentration of matrix metalloproteinases (MMPs) in the cerebrospinal fluid (CSF) of these patients.

OUTLINE: Patients are stratified according to disease type (acute lymphoblastic leukemia vs. other leukemia/lymphoma vs medulloblastoma vs other solid tumors). (Recurrent CNS acute lymphoblastic leukemia stratum only open to accrual as of 11/30/04)

INDUCTION: Patients receive topotecan hydrochloride intrathecally (IT) over 5 minutes twice weekly for 6 weeks.

CONSOLIDATION: Beginning 1 week after completion of induction, patients receive topotecan hydrochloride IT over 5 minutes weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Beginning 2 weeks after completion of consolidation, patients receive topotecan hydrochloride IT over 5 minutes twice monthly for 4 months and then monthly through year 1.

After completion of study treatment, patients are followed up monthly for 3 months, every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 14-77 patients will be accrued for this study.

Being tested
topotecan hydrochloride, laboratory biomarker analysis
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Meningeal Carcinomatosis, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dendritic Cell Sarcoma, Interdigitating, Medulloblastoma, Burkitt Lymphoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • topotecan hydrochlorideDrug

    Also called hycamptamine, Hycamtin, SKF S-104864-A, TOPO

    Given IT

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00005811
Study groupRoleWhat they receive
Treatment (topotecan hydrochloride)ExperimentalINDUCTION: Patients receive topotecan hydrochloride IT over 5 minutes twice weekly for 6 weeks. CONSOLIDATION: Beginning 1 week after completion of induction, patients receive topotecan hydrochloride IT over 5 minutes weekly for 4 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Beginning 2 weeks after completion of consolidation, patients receive topotecan hydrochloride IT over 5 minutes twice monthly for 4 months and then monthly through year 1.
Receives: Drug: topotecan hydrochloride; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. For the leukemia and lymphoma patients, an objective response rate, defined to be the proportion of Complete Responses of less than 0.10

    Measured: Up to 54 months

  2. For the patients with solid tumors, a proportion of patients who do not experience an event, defined to be death, progressive disease, relapse, or second malignancy of less than 0.3

    Measured: Up to 54 months

  3. Safety and toxicity

    Measured: Up to 54 months

  4. Concentration of matrix metalloproteinases in the CSF

    Measured: Up to 54 months

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 startApr 2000
  3. Primary completionApr 2006
  4. Study completionFeb 2009

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005811
Sponsor's protocol ID
NCI-2012-01848
Other IDs
P9962, U10CA098543, CDR0000067813
Status last verified
Feb 2013
First submitted
2 Jun 2000
Last updated
21 Feb 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing topotecan hydrochloride and laboratory biomarker analysis in people with AIDS-related Diffuse Large Cell Lymphoma and AIDS-related Diffuse Mixed Cell Lymphoma, run by National Cancer Institute (NCI) 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?

The sponsor lists 40 inclusion and 0 exclusion criteria. 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 21 Feb 2013. 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.

What does the primary outcome measure?

For the leukemia and lymphoma patients, an objective response rate, defined to be the proportion of Complete Responses of less than 0.10 (time frame: Up to 54 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005811.

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 21 Feb 2013.

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