Clinical Trials

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  • Protocol Title:
    Primary Central Nervous System Lymphoma

    A Phase I/II Study of Patients with Newly Diagnosed Primary Central Nervous System Lymphoma Treated with Methotrexate/BBBD, and Adding Rituximab (an anti CD-20 Antibody) and Carboplatin to the Treatment Regimen

    Protocol Summary:

    The purpose of this study is to evaluate the safety and tolerability of chemotherapy delivered in conjunction with a special technique called blood-brain barrier disruption (BBBD) in patients with primary central nervous system lymphoma (PCNSL) who have not undergone prior cranial or spinal radiotherapy. Participants of this study will be hospitalized for approximately three days every four weeks, to receive chemotherapy. The drug rituximab will be administered intravenously, the evening prior to carboplatin (intra-arterial) and methotrexate (intra-arterial) chemotherapy. The two chemotherapy drugs will be administered in conjunction with BBBD. If the patient has lymphoma in the eye, chemotherapy will be given into the eye(s) as well. Participants will receive the drug sodium thiosulfate (intra-venous) four and eight hours after carboplatin, in an effort to reduce side effects associated with this chemotherapy regimen. The treatment may continue for up to 12 months in the absence of disease progression or unacceptable side effects.

    Major Eligibility Criteria:
    • Primary central nervous system lymphoma (PCNSL)
    • No prior cranial or spinal radiotherapy
    • No systemic lymphoma
    • No more than 90 days since diagnosis of PCNSL
    • Must be HIV negative
    • Must be Hepatitis B and Hepatitis C negative
    • Age 18 to 75 years
  • Protocol Title:
    Anaplastic Oligodendroglioma

    Phase I/II Study of Carboplatin, Melphalan and Etoposide Phosphate in Conjunction with Osmotic Opening of the Blood-Brain Barrier and Delayed Intravenous Sodium Thiosulfate Chemoprotection, in Subjects with Anaplastic Oligodendroglioma or Oligoastrocytoma

    Protocol Summary:

    The purpose of this study is to evaluate the safety and tolerability of chemotherapy delivered in conjunction with a special technique called blood-brain barrier disruption (BBBD) in patients with anaplastic oligodendroglioma or oligoastrocytoma. The study will also examine the efficacy (one year progression free survival) of the chemotherapy. Participants of this study will be hospitalized for approximately three days every four weeks, to receive chemotherapy. Chemotherapy drugs will include carboplatin (intra-arterial), melphalan (intra-arterial), and etoposide phosphate (intravenous). The three chemotherapy drugs will be administered in conjunction with BBBD. Participants will receive the drug sodium thiosulfate (intravenous) four and eight hours after carboplatin, in an effort to reduce side effects associated with this chemotherapy regimen. The treatment may continue for up to 12 months in the absence of disease progression or unacceptable side effects.

    Major Eligibility Criteria:
    • Anaplastic Oligodendroglioma or Oligoastrocytoma
    • Prior treatment with Temozolomide
    • Prior consultation with radiation oncology
    • Aged 18 to 75 years old
    • Other eligibility criteria may apply
  • Protocol Title:
    High-Grade Glioma

    Phase II Clinical Trial of Patients with High-Grade Glioma Treated with Intra-arterial Carboplatin-based Chemotherapy, Randomized to Treatment with or without Delayed Intravenous Sodium Thiosulfate as a Potential Chemoprotectant against Severe Thrombocytopenia

    Protocol Summary:

    The purpose of this study is to evaluate if the drug called sodium thiosulfate prevents a severe decrease in a particular type of blood cell (platelets) in patients who are being given carboplatin, cyclophosphamide, and etoposide phosphate for the treatment of high-grade glioma. This is a randomized study meaning that neither the participant nor their doctor may choose to which treatment group the participant is assigned. All participants of this study receive the chemotherapy drugs carboplatin (intra-arterial), cyclophosphamide (intravenous) and etoposide phosphate (intravenous). Participants will be randomized in two groups. Group 1 will receive the chemotherapy drugs, but not the sodium thiosulfate. Group 2 will receive the chemotherapy drugs, followed by the sodium thiosulfate (intravenous), four and eight hours after the chemotherapy.

    Major Eligibility Criteria:
    • High-grade glioma
    • Age 18 to 75 years old
    • Other eligibility criteria may apply