TPI 287 in Patients With Recurrent Glioblastoma Multiforme
Condition: Brain Cancer
MeSH terms: Glioblastoma; Brain Neoplasms
Intervention: TPI 287
Intervention description: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Brain Tumor; Central Nervous System; CNS; Glioblastoma Multiforme; GBM; TPI 287; Radiation Therapy; Temozolomide; Chemotherapy; taxanes

Summary:

      The goal of this clinical research study is to learn if TPI 287 can help to control
      glioblastoma. The safety of this drug will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have histological or cytological documentation of GBM. Patients will be
             eligible if the original histology was lower grade glioma and a subsequent diagnosis
             of glioblastoma or gliosarcoma is made.

          2. Patients must have supratentorial GBM that has radiographic recurrence or progression
             following prior radiation therapy and temozolomide for GBM or lower grade glioma, or
             the appearance of new lesions on scan, or clinical or neurologic worsening despite
             stable disease on the last 2 scans.

          3. Patients must have measurable disease on radiologic scan.

          4. Patients must be >/= 18 years of age.

          5. Patients must have a Karnofsky performance status >/= 60%.

          6. Patients must have adequate bone marrow as evidenced by an absolute neutrophil count
             >/=1,500/uL and a platelet count >/=100,000/uL.

          7. Patients must have adequate renal function as evidenced by serum creatinine <= the
             upper limit of normal (ULN)

          8. Patients must have adequate hepatic function as evidenced by serum total bilirubin </=
             2.0 mg/dL and aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT
             or SGPT) </= 3 times the ULN.

          9. Patients must have recovered from the effects of any prior surgery, radiotherapy or
             other chemotherapy with any therapy related adverse events revolved to </= grade 1,
             and at least 12 weeks must have elapsed from the completion of radiotherapy, and 3
             weeks from the last dose of Temozolomide.

         10. Women of child-bearing potential (includes women who are menopausal for less than 1
             year and not surgically sterilized) must have a negative urine or serum pregnancy test
             at screening.

         11. Sexually active patients must agree to use adequate contraception (two barrier
             methods) for the duration of the study.

         12. Patients or their legal representative must be able to read, understand and sign an
             informed consent form (ICF).

        Exclusion Criteria:

          1. Patients who have received more than one course of radiation therapy or more than a
             total dose of 65 grey (Gy). Patients may have received radiosurgery as part of the
             initial therapy (i.e., in addition to one course of radiation therapy); however, the
             dose used for the radiosurgery counts against the total dose limit listed above.

          2. Patients who have had a second surgery for recurrent disease who have no
             radiologically apparent residual disease (contrast-enhanced MRI imaging must have been
             performed within 24-48 hours post-operatively).

          3. Patient who have received any cytotoxic chemotherapy for treatment of GBM other than
             temozolomide (Gliadel trademarked as part of the initial therapy is permitted).
             However, patients who have received prior biologic therapy will be eligible.

          4. Patients who are receiving concurrent enzyme-inducing anti-epileptic drugs (EIAEDs)
             (e.g., carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital and
             primidone) or who received EIAEDs within 2 weeks prior to the first dose of study
             drug.

          5. Patients who are not on a stable or decreasing steroid dose for the previous week
             prior to the study enrollment.

          6. Patients with an active infection or with a fever >/= 38.5°C within 3 days prior to
             the study enrollment.

          7. Patients who have history of prior malignancy within the past 5 years except for
             curatively treated non-melanoma skin cancer or cervical intra-epithelial neoplasia for
             which the patient has been disease-free for at least 3 years.

          8. Patients with Grade 2 or higher peripheral neuropathy.

          9. Patients with New York Heart Association(NYHA) Class 3 or 4 congestive heart failure.

         10. Patients with known HIV or Hepatitis B or C.

         11. Patients who are pregnant or lactating.

         12. Patients with any other medical condition, including mental illness or substance
             abuse, deemed by the Investigator to be likely to interfere with the patient's ability
             to sign the ICF or his/her ability to cooperate and participate in the study, or to
             interfere with the interpretation of the results.

         13. Patients who have received prior bevacizumab therapy.