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TPI 287 in Patients With Recurrent Glioblastoma Multiforme

This study has been terminated.
(Low Accrual)
Sponsor:
Collaborator:
Cortice Biosciences, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01113463
First received: April 27, 2010
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Brain Cancer
Drug: TPI 287
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open-Label Study of the Efficacy of TPI 287 in Patients With Glioblastoma Multiforme That Has Recurred or Progressed Following Prior Therapy With Radiation Plus Temozolomide

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression-Free Survival Rate [ Time Frame: After 9 x 21-day Cycles (6 months) ] [ Designated as safety issue: No ]
    Patients who are alive without documented evidence of disease progression will be determined to be "progression free" at each study time point. As well, progression-free survival will be calculated from the date of Day 1 Cycle 1 to the date that criteria for progression of disease is first seen.


Enrollment: 17
Study Start Date: April 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TPI 287
TPI 287 Starting dose 160 mg/m^2 IV every 3 weeks
Drug: TPI 287
Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) intravenous (IV) infusion once every 3 weeks, (i.e., 1 cycle = 21 days).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 SGOT/SGPT </= 3 x 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 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 (GliadelTM 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113463

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cortice Biosciences, Inc.
Investigators
Study Chair: Charles A. Conrad, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01113463     History of Changes
Other Study ID Numbers: 2009-0759, NCI-2011-01303
Study First Received: April 27, 2010
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Brain Tumor
Central Nervous System
CNS
Glioblastoma Multiforme
GBM
TPI 287
Radiation Therapy
Temozolomide
Chemotherapy
taxanes

Additional relevant MeSH terms:
Brain Neoplasms
Glioblastoma
Astrocytoma
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on November 27, 2014