A Phase I Study of ABT 510 for Newly Diagnosed Glioblastoma Multiforme

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louis Burt Nabors, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00584883
First received: December 26, 2007
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

To determine the maximum tolerated dose of ABT 510 when administered concurrent with radiation therapy for patients with newly diagnosed glioblastoma multiforme.


Condition Intervention Phase
Brain Tumor
Drug: ABT 510
Phase 1

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

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • All patients enrolled in this study will be statistically characterized for baseline and disease characteristics using descriptive statistics for continuous measures. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 24
Study Start Date: August 2003
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ABT 510
    ABT 510 (TSP-1 mimetic peptide) is a parenterally available nonapeptide analog of the heptapeptide and is a potent inhibitor of angiogenesis. ABT 510 competes with TSP-1 for binding to endothelial cells, but the exact mechanism of anti-angiogenesis is unknown. ABT 510 is administered by SQ injection. The starting dose of ABT 510 will be 20mg once daily (QD) SQ. Doses will be escalated by approximately 50% increments in consecutive cohorts of 3-6 patients until maximum tolerated dose is achieved.
Detailed Description:
  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).
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 document.

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.

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  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: NCT00584883

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Louis B Nabors, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Louis Burt Nabors, MD, Professor, Neurology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00584883     History of Changes
Other Study ID Numbers: UAB 0327, ABT510
Study First Received: December 26, 2007
Last Updated: May 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
Patients who have newly diagnosed brain tumors

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

ClinicalTrials.gov processed this record on July 31, 2014