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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00061672
First received: June 2, 2003
Last updated: August 13, 2007
Last verified: August 2007
  Purpose

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


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Hodgkin's Lymphoma
Drug: ABT-510 - Thrombospondin-1 Mimetic
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating the Safety and Effectiveness of ABT-510 in Subjects With Refractory Lymphoma

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Response rate [ Time Frame: One year ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: One year ]
  • Overall survival [ Time Frame: One year ]
  • Performance status [ Time Frame: One year ]

Enrollment: 67
Study Start Date: April 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00061672

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

No publications provided

ClinicalTrials.gov Identifier: NCT00061672     History of Changes
Other Study ID Numbers: M02-457
Study First Received: June 2, 2003
Last Updated: August 13, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Non-Hodgkin's Lymphoma (NHL)
Hodgkin's Lymphoma (HL)

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014