Clinical trial NCT00515788 (phase 1, status: terminated)
Conditions: neoplastic meningitis
ICD codes: I78.1, D63.0, M36.1, Q82.5, R53.0, G73.1, M36.0
Drugs: depocyt, temozolomide
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O, CSCC[C@H](N)C(O)=O
Reason stopped: 
    study terminated due to slow accrual with no expansion to additional phase.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Patients must be >/=18 years of age

          2. All patients with the exception of those with primary brain tumors, must have
             histologic diagnosis of systemic malignancy. Patients must have the presence of
             malignant cells in CSF (+CSF) or clinical signs and symptoms of leptomeningeal disease
             and radiographic abnormalities without malignant cells identified in the CSF (-CSF).
             Clinical signs/symptoms include cerebral hemispheric, cranial nerve, and/or spinal
             cord/root dysfunction.

          3. Patients must have Karnofsky performance status of >/=60%. Patients who are unable to
             walk because of paralysis, but who are up in a wheelchair, will be considered
             ambulatory for the purposes of the performance score.

          4. Patients must have recovered from the acute toxic effects of all prior chemotherapy,
             immunotherapy, or radiotherapy, before entering the study and must be without
             significant systemic illness. Patients must not have received any systemic therapy for
             Leptomeningeal disease (LMD) within 3 wks (6 wks if a nitrosourea), intrathecal
             chemotherapy within 1 wk, or irradiation within 8 wks prior to treatment on this
             study. Patients previously receiving craniospinal irradiation must have positive
             cytology or progression of meningeal disease on MRI scan. Patients must not have
             received whole brain or focal CNS radiotherapy within 1 wk of treatment.

          5. Patients must have a platelet count >/= 75,000/mm(3) and ANC >/= 1500/mm(3) within 72
             hours prior to intrathecal DepoCyt and temozolomide treatment.

          6. Patients must have adequate liver function, total bilirubin < 2.0 mg%; SGPT < 5 times
             normal; adequate renal function (serum creatinine </= 1.5 mg); and normal metabolic
             parameters (serum electrolytes, calcium, magnesium, and phosphorus).

          7. All patients or their legal guardians must sign a document of informed consent
             indicating their awareness of the investigational nature and the risks of this study.

          8. Ventricular access devices (e.g. an Ommaya reservoir) are mandatory.

        Exclusion Criteria:

          1. Patients receiving other therapy (either intrathecal or systemic) designed
             specifically to treat their leptomeningeal disease are not eligible for this study.
             However, patients receiving concomitant non-cytotoxic therapy (hormonal or cytostatic
             therapy) to control systemic disease or bulk CNS disease will be eligible, provided
             the therapy is not a phase I agent, an agent which significantly penetrates the CSF or
             an agent known to have serious unpredictable CNS side effects.

          2. (1. continued) No other cytotoxic chemotherapies are allowed (non-cytotoxic therapies
             such as herceptin, tarceva, arimidex etc are allowed at the investigator's
             discretion). Careful documentation of concurrently administered systemic drugs is
             required.

          3. Patients with clinical evidence of obstructive hydrocephalus or compartmentalization
             of the CSF flow as documented by radioisotope Indium-(111) (Technetium(99) -DTPA when
             Indium-(111) unavailable) flow study are not eligible for this protocol. CSF
             obstruction will be determined by routine nuclear medicine CSF flow study parameters.
             If patients have evidence of block that is subsequently proven to be relieved after
             focal XRT, these patients can enroll immediately after repeat flow study shows block
             to be relieved.

          4. Patients with a ventriculoperitoneal (VP) or ventriculoatrial (VA) shunt must have an
             on/off device in their shunt systems to be eligible for the study. Patients must be
             able to tolerate shunt closure for >/= 4 hours without development of clinical signs
             of increased intracranial pressure. Patients unable to tolerate shunt closure for >/=
             4 hours will not be eligible for the study.

          5. Women of childbearing potential (females who are not surgically sterile or who have
             had a period in the last 12 months) must have a negative serum pregnancy test and must
             not be lactating.

          6. Patients with any uncontrolled infection (life-threatening infection resistant to
             treatment after 7 days) are not eligible for this study, except those with HIV and
             AIDS-related lymphomatous meningitis).

          7. Use of any other investigational drug within 7 days prior to study entry. This period
             should be extended if the patient has received any investigational agent that is known
             to have delayed toxicities after 7 days or a prolonged half-life.

          8. Patients not able to undergo magnetic resonance testing. i.e. pacemaker.

          9. Patients may not have had prior treatment with Temozolomide.