Clinical trial NCT00112619 (phase 1, status: terminated)
Conditions: brain and central nervous system tumors, carcinoma of unknown primary, leukemia, lymphoma, unspecified childhood solid tumor, protocol specific
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: topotecan hydrochloride
SMILES: CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O
Reason stopped: 
    slow accrual and company withdrawing support to supply the drug
  
Eligibility criteria:

        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