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A Phase I Study of ABT 510 and Concurrent Temozolomide and Radiotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme

Phase 1
19 Years
Not Enrolling
Brain Tumor

Thank you

Trial Information

A Phase I Study of ABT 510 and Concurrent Temozolomide and Radiotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme

1. To describe the toxicity associated with this regimen in adult patients with newly
diagnosed glioblastoma multiforme.

2. To determine the duration of disease free survival and overall survival associated with
this therapy.

3. Evaluate thrombospondin 1 (TSP-1) and 2 (TSP-2) in tumor vs. corresponding normal
tissue using quantitative real time Polymerase Chain Reaction (Q-RT-PCR).

4. Determine the effect of ABT 510 on tumor permeability and tumor blood volume as
measured by non-invasive Magnetic Resonance Imaging (MRI).

Inclusion Criteria:

1. Patients must be 19 years of age or older.

2. Patients must have histologically proven newly diagnosed glioblastoma multiforme.

3. Patients must have fully recovered from the immediate post-operative period and be
maintained on a stable corticosteroid regimen for 5 days prior to entry.

4. Patients must have a Karnofsky performance status > 60% (i.e. the patient must be
able to care for himself/herself with occasional help from others).

5. Patients must have adequate hematologic, renal and liver function (i.e. Absolute
neutrophil count > 1500/mm3, Platelets > 100,000/mm3, creatinine 1.5 mg/dl .

6. Women of childbearing potential must have a negative pregnancy test.

7. Patients with the potential for pregnancy or impregnating their partner must agree to
follow acceptable birth control methods to avoid conception. The effect of the
investigational drugs on the developing human fetus is not known, but these drugs are
likely to be harmful to the developing fetus or nursing infant. Women of
child-bearing potential must agree to use adequate contraception (either surgical
sterilization; approved hormonal contraceptives such as birth control pills
Depo-Provera, or Lupron Depot; barrier methods such as condom or diaphragm along with
spermicide; or an Intrauterine device (IUD)). Should a woman become pregnant or
suspect she is pregnant while participating in this study, she should inform her
treating physician and study PI immediately.

8. The patient is able to self-administer or has a caregiver who can reliably administer
subcutaneous injections.

9. Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

1. Pregnant or breast feeding.

2. Prior therapy for the brain tumor (except surgery)

3. Prior treatment with antineoplastic agents.

4. Exclude sexually active males and females unwilling to practice contraception during
the study.

5. Serious concurrent infections.

6. Clinically significant cardiac disease not well controlled with medication (e.g.
congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias
) or myocardial infarction within the last 12 months.

7. Patients who have had prior cytotoxic chemotherapy prior to radiation therapy.

8. Patients with other serious uncontrolled co-morbid diseases that the investigator
feels may comprise the study findings.

9. Patients must be able to learn to self -administer or have another person administer
subcutaneous(SQ) injections.

10. Patients who have received any other investigational agents within the 28 days prior
to Day 1 of the study.


Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

All patients enrolled in this study will be statistically characterized for baseline and disease characteristics using descriptive statistics for continuous measures.

Outcome Description:

The primary outcome for the study was safety and to define the MTD (max tolerated dose). Also, survival was to be measured but the study was not powered to statistically have significance for that measure.

Outcome Time Frame:

up to 2 years

Safety Issue:


Principal Investigator

Louis B Nabors, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Food and Drug Administration

Study ID:

UAB 0327



Start Date:

August 2003

Completion Date:

July 2008

Related Keywords:

  • Brain Tumor
  • Patients who have newly diagnosed brain tumors
  • Brain Neoplasms
  • Glioblastoma



University of Alabama at Birmingham Birmingham, Alabama  35294-3300