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Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain Clinical research trials and Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain. Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain clinical trial. Test subjects typically receive the most effective healthcare possible for their Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain  Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain
Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain
For Condition: leptomeningeal metastases
Status: No longer recruiting
Sponsor(s): Kaplan Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /65 Years
Genders: Both
Protocol Entry Criteria: 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: - 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 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonathanFinlay, Study Chair, Kaplan Cancer Center
CHU Pitie-Salpetriere
Paris, , 75651
France
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: CDR0000068949; NYU-0005H,NCI-G01-2018,NYU-0041H
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025311
Other Leptomeningeal Metastases Studies:
1. Gemcitabine in Treating Neoplastic Meningitis in Patients With Leukemia, Lymphoma, or Solid Tumors
2. Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
3. Intrathecal Gemcitabine in Treating Patients With Cancer and Neoplastic Meningitis
4. Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
5. Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors
Related Studies:
Other leptomeningeal metastases Clinical Trials
Other Clinical Trials
Other Paris Clinical Trials
Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain
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