TPI 287 in Patients With Recurrent Glioblastoma Multiforme

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT01113463
• Date of registration: 27/04/2010
• Primary sponsor: M.D. Anderson Cancer Center
• Public title: TPI 287 in Patients With Recurrent Glioblastoma Multiforme
• Scientific 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
• Date of first enrolment: April 2010
• Target sample size: 17
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01113463
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Charles A. Conrad, MD
• Affiliation: UT MD Anderson Cancer Center

Key inclusion & exclusion 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

9. Patients must have recovered from the effects of any prior surgery, radiotherapy or
other chemotherapy with any therapy related adverse events revolved to 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Brain Cancer

Intervention(s)

Drug: TPI 287

Primary Outcome(s)

Progression-Free Survival Rate [Time Frame: After 9 x 21-day Cycles (6 months)]

Secondary ID(s)

2009-0759

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Archer Biosciences, Inc.