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Status:

TERMINATED

Topotecan in Treating Young Patients With Neoplastic Meningitis Due to Leukemia, Lymphoma, or Solid Tumors

Lead Sponsor:

Pediatric Brain Tumor Consortium

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Carcinoma of Unknown Primary

Eligibility:

All Genders

3-21 years

Phase:

PHASE1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of intraventricular topotecan in young patients with neoplastic meningitis secondary to leukemia, lymphoma, or solid tumors. * Determ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of neoplastic meningitis secondary to leukemia, lymphoma (including AIDS-related lymphoma), or solid tumor (including primary CNS tumors or carcinomas of unknown primary site), defined by 1 of the following criteria:
  • Cerebral spinal fluid (CSF) cell count \> 5/μL AND evidence of blast cells on cytospin or by cytology (for patients with leukemia or lymphoma)
  • Presence of tumor cells on cytospin or cytology OR unequivocal presence of meningeal disease by MRI (for patients with solid tumor)
  • No conventional therapy for neoplastic meningitis exists
  • Patients with CNS leukemia or lymphoma must be refractory to conventional therapy, including radiotherapy (i.e., second or greater relapse)
  • Patients with CNS leukemia or lymphoma must have had a negative bone marrow aspiration within the past 2 weeks
  • No clinical evidence of obstructive hydrocephalus
  • No compartmentalization of CSF flow by radioisotope indium In 111 or technetium Tc 99 DTPA flow study
  • No ventriculoperitoneal or ventriculoatrial shunt unless patient is completely shunt-independent
  • No impending spinal cord compression or other CNS involvement (e.g., acute visual loss secondary to optic nerve involvement) requiring emergent local radiotherapy
  • PATIENT CHARACTERISTICS:
  • Age
  • 3 to 21
  • Performance status
  • Lansky 60-100% (≤ 16 years of age) OR
  • Karnofsky 60-100% (\> 16 years of age)
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Not specified
  • Hepatic
  • Not specified
  • Renal
  • Calcium ≥ 7 mg/dL
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Sodium 125-150 mmol/L
  • Magnesium ≥ 0.7 mmol/L
  • Must have or be willing to have an intraventricular access device (i.e., Ommaya reservoir)
  • No uncontrolled infection
  • HIV-positive patients with AIDS-related lymphomatous meningitis are eligible
  • No other significant uncontrolled systemic medical illness that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Recovered from prior biologic therapy or immunotherapy
  • Chemotherapy
  • Recovered from prior chemotherapy
  • At least 1 week since prior intra-colony stimulating factory (CSF) chemotherapy (2 weeks for liposomal cytarabine)
  • At least 3 weeks since prior systemic chemotherapy for leptomeningeal disease
  • Concurrent systemic chemotherapy to control systemic disease or bulk CNS disease allowed provided the systemic chemotherapy is not an investigational agent OR any of the following:
  • High-dose (\> 1 g/m\^2) methotrexate
  • High-dose (\> 1 g/m\^2) cytarabine
  • Fluorouracil
  • Capecitabine
  • Thiotepa
  • Nitrosoureas
  • Topotecan
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • See Disease Characteristics
  • At least 8 weeks since prior craniospinal radiotherapy and recovered
  • No concurrent CNS radiotherapy
  • Concurrent radiotherapy to extra-CNS sites (e.g., painful bone metastases not in the craniospinal axis) allowed
  • Surgery
  • Not specified
  • Other
  • More than 2 weeks since prior and no other concurrent investigational agents
  • No other concurrent intra-CSF or systemic therapy for leptomeningeal disease

Exclusion

    Key Trial Info

    Start Date :

    August 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    19 Patients enrolled

    Trial Details

    Trial ID

    NCT00112619

    Start Date

    August 1 2005

    Last Update

    June 30 2011

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, United States, 94115

    2

    Children's National Medical Center

    Washington D.C., District of Columbia, United States, 20010-2970

    3

    Children's Memorial Hospital - Chicago

    Chicago, Illinois, United States, 60614

    4

    Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, United States, 20892-1182