Non Hodgkin Lymphoma Clinical Trial

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

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

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

77

Study ID:

NCT00005811

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Children's Oncology Group
Arcadia California, 91006, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

77

Study ID:

NCT00005811

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider