MDACC Study Summary 2009-0759 (Archived)

Study Summary
No. 2009-0759:.......Brain; CNS......Charles A. Conrad......Neuro Oncology

Study Summary Title



Study Summary Number:	2009-0759

Study 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

Physician

New Patient Referral



Name:	Charles A. Conrad	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Neuro Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2883 Contact us about clinical trials

General Information



Disease Group:	Brain CNS	Supported By:	Archer Biosciences, Inc

Phase of Study:	Phase II	Return Visit:	Every 3 weeks

Treatment Agents:	TPI 287	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	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.

Study Objectives / Outcomes

Primary Objective

The primary objective of this study is to determine the efficacy of TPI 287 as measured by the progression free survival (PFS) rate in patients who have supratentorial glioblastoma multiforme (GBM) that has recurred or progressed following prior radiation therapy and temozolomide.

Secondary Objectives

Objective response rates, as determined by patients who experience Complete Response (CR)or Partial Response (PR) per MacDonald criteria
Duration of response
Time to treatment failure
Overall survival(OS)
Incidence and severity of treatment-related adverse events
Safety of co-administration of bevacizumab (Avastin™) for necrotic lesions

Study Status Information



Study Activation / Registration Date:	04/27/2010

IRB Review and Approval Date:	04/27/2010

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT01113463
Study Information on Clinical Trials Registry (clinicaltrials.gov)