Open-Label, Non-Randomized, Dose-Escalation Study of the Safety and Tolerability of Concurrent Administration of ABT 510 - Full Text View

Sponsored by:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00584883

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 I

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Temozolomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1 Study of ABT 510 and Concurrent Temozolomide and Radiotherapy for Patients With Newly Diagnosed Glioblastma Multiforme

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

Primary Outcome Measures:

All patients enrolled in this study wil be statistically characterized for baseline and disease characteristics using descriptive statistics for continuous measures. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	August 2003
Study Completion Date:	October 2007
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Intervention Details:

ABT 510 (TSP-1 mimetic peptide) is a parenteraly 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 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:

To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme.
To determine the duration of disease free survival and overall survival associated with this therapy.
Evaluate thrombospondin 1 (TSP-1) and 2 (TSP-2) in tumor vs. corresponding normal tissue using quantitative real time PCR (Q-RT-PCR).
Determine the effect of ABT 510 on tumor permeability and tumor blood volume as measured by non-invasive MRI.

Eligibility

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

Criteria

Inclusion Criteria:

Patients must be 19 years of age or older.
Patients must have histologically proven newly diagnosed glioblastoma multiforme.
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.
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).
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 .
Women of childbearing potential must have a negative pregnancy test.
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 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.
The patient is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Pregnant or breast feeding.
Prior therapy for the brain tumor (except surgery)
Prior treatment with antineoplastic agents.
Exclude sexually active males and females unwilling to practice contraception during the study.
Serious concurrent infections.
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.
Patients who have had prior cytotoxic chemotherapy prior to radiation therapy.
Patients with other serious uncontrolled co-morbid diseases that the investigator feels may comprise the study findings.
Patients must be able to learn to self -administer or have another person administer SQ injections.
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

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

Responsible Party:	University of Alabama at Birmingham ( Louis Burton Nabors, MD )
Study ID Numbers:	F030804016, ABT510
Study First Received:	December 26, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00584883
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:

Patients who have newly diagnosed brain tumors

Study placed in the following topic categories:

Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms

Brain Diseases
Temozolomide
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009