Study Evaluating the Safety and Effectiveness of ABT-510 in Subjects With Refractory Lymphoma

August 13, 2007 updated by: Abbott

A Phase II Study Evaluating the Safety and Effectiveness of ABT-510 in Subjects With Refractory Lymphoma

The primary objective of this study is to assess the safety and effectiveness of ABT-510 in subjects with refractory lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Hematology Oncology Associates
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center
    • California
      • Los Angeles, California, United States, 90033
        • USC - Norris Cancer Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • The Center for Hematology-Oncology
      • Miami, Florida, United States, 33176
        • Oncology-Hematology Group of South Florida
      • Orlando, Florida, United States, 32806
        • Cancer Centers of Florida, P.A.
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Oncology and Hematology Group
      • St. Louis, Missouri, United States, 63142
        • Arch Medical Services, INC.
    • New York
      • Albany, New York, United States, 12208
        • Albany Regional Cancer Center
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Raleigh Hematology Oncology Clinic
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Cancer Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Hematology Oncology Associates
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • U of W - Comprehensive Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

A subject will be eligible for study participation if all of the following criteria are met:

  • The subject is at least 18 years of age.
  • The subject has histologically confirmed non-Hodgkin's Lymphoma (NHL) (excluding Burkitt's, Burkitt's type or HIV associated lymphoma) or Hodgkin's Lymphoma (HL) that is refractory to or has relapsed after standard therapy or for which there is no known effective treatment.
  • The subject must have measurable disease by the CHESON Criteria for Tumor Response.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
  • The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.

  • The subject must have adequate bone marrow, renal and hepatic function as follows:

    • Bone marrow: *White blood cell count (WBC) greater than or equal to 3,000/mm3; *Platelets greater than or equal to 75,000/mm3 unless subject has received a prior transplant or bone marrow involvement with lymphoma has been documented, then platelets of equal to or greater than 50,000 is acceptable. *Hemoglobin greater than or equal to 8.5 g/dL; *ANC greater than or equal to 1000/mm3
    • Renal function: *Serum creatinine less than or equal to 2.0 mg/dL
    • Hepatic function: *AST and ALT less than or equal to 3.0 X ULN
  • The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed appropriate by the investigator while in the study and up to two months following completion of therapy.
  • The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.

Exclusion Criteria:

A subject will be ineligible for study participation if any of the following criteria are met:

  • The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases.
  • The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g., low dose Coumadin) for catheter prophylaxis is permitted; PT/PTT must be within normal limits.
  • The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks of Study Day 1) or currently exhibits other clinically significant events of bleeding.
  • The subject has received any therapy for lymphoma including chemotherapy, antibody therapy, radiotherapy or any investigational therapy within four weeks prior to study drug administration.
  • The subject has been initiated on steroids or there is an increase in current steroid dose within three months prior to study drug administration.
  • The subject exhibits evidence of clinically significant uncontrolled condition(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
  • The subject has history of other previous malignancies within 5 years, with the exception of: Adequately treated in situ carcinoma of the cervix; Basal or squamous cell carcinoma of the skin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: One year
One year
Overall survival
Time Frame: One year
One year
Performance status
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Rod Humerickhouse, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Registration Dates

First Submitted

June 2, 2003

First Submitted That Met QC Criteria

June 3, 2003

First Posted (Estimate)

June 4, 2003

Study Record Updates

Last Update Posted (Estimate)

August 15, 2007

Last Update Submitted That Met QC Criteria

August 13, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-457

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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