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Phase I Study of Intrathecal Topotecan

This study has been completed.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001333
  Purpose

The purpose of this study is to determine the qualitative and quantitative toxicity of intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy).


Condition Intervention Phase
Leukemia
Lymphoma
Meningeal Neoplasms
Drug: topotecan
Phase I

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma   

Drug Information available for:   Topotecan hydrochloride    Topotecan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   Phase I Study of Intrathecal Topotecan

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   30
Study Start Date:   February 1993
Estimated Study Completion Date:   December 2000

Detailed Description:

The purpose of this study is to determine the qualitative and quantitative toxicity of intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy). A safe dose of topotecan that can be recommended for intrathecal administration in subsequent phase II studies will be established in a limited dosage escalation schedule. The CSF pharmacokinetics of intrathecal topotecan will also be studied. Topotecan will be administered intrathecally on a bi-weekly basis for four to six weeks, followed by weekly administration for 1 month, twice monthly administration for four months and then monthly IT administration.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

Leukemia, lymphoma, or solid tumor with overt meningeal involvement considered refractory to conventional therapy.

CSF leukemic cell count at least 5 per cubic millimeter with evidence of blast cells on cytospin or cytology required for leukemia and lymphoma patients.

Tumor cells on cytospin or cytology or measurable meningeal disease on CT or MRI required for patients with solid tumors.

No clinical evidence of obstructive hydrocephalus or compartmentalization of the CSF flow as documented by indium-111- or technetium-99-DPTA flow study.

PRIOR/CONCURRENT THERAPY:

At least 1 week since CNS therapy.

Biologic Therapy: Recovery from toxic effects of prior immunotherapy required.

Chemotherapy:

Recovery from toxic effects of prior chemotherapy required.

No concomitant therapy to treat meningeal malignancy (intrathecal or systemic).

Concomitant chemotherapy to control systemic disease or bulk CNS disease allowed except: Investigational agents. Agents that penetrate the CNS (e.g., high-dose methotrexate, thiotepa, high-dose cytarabine, fluorouracil, intravenous mercaptopurine).

Agents known to have serious unpredictable CNS side effects.

Endocrine Therapy: Not specified.

Radiotherapy: Recovery from toxic effects of prior radiotherapy required. Patient eligible if flow restored following focal radiotherapy to the blockage site.

Surgery: Not specified.

PATIENT CHARACTERISTICS:

Age: 3 and over (older patients giving consent will be enrolled before the very young, if possible).

Performance status: ECOG 0-2.

Life expectancy: At least 8 weeks.

Hematopoietic: See Disease Characteristics.

Hepatic: Bilirubin less than 2.0 mg/dL, SGPT less than 3 times normal.

Renal: Creatinine less than 1.5 mg/dL.

Metabolic: Serum electrolytes (including calcium and phosphate) normal.

Other: No significant systemic illness (e.g., infection). Not pregnant or lactating.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001333

Locations
United States, Maryland
National Cancer Institute (NCI)    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators
  More Information


Publications:

Study ID Numbers:   930085, 93-C-0085
First Received:   November 3, 1999
Last Updated:   March 3, 2008
ClinicalTrials.gov Identifier:   NCT00001333
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Intraventricular  
Meningeal Malignancy  
NSC 609699  
SKF 104864  
Topoisomerase 1  

Study placed in the following topic categories:
Lymphatic Diseases
Leukemia
Meningeal Neoplasms
Immunoproliferative Disorders
Central Nervous System Neoplasms
Topotecan
Lymphoproliferative Disorders
Lymphoma
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Nervous System Diseases
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008




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