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

This study has been completed.

Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00061672
  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 II

MedlinePlus related topics:   Hodgkin's Disease    Lymphoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Study Evaluating the Safety and Effectiveness of ABT-510 in Subjects With Refractory Lymphoma

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061672

Locations
United States, Arizona
Arizona Clinical Research Center    
      Tucson, Arizona, United States, 85712
Hematology Oncology Associates    
      Phoenix, Arizona, United States, 85012
United States, California
USC - Norris Cancer Center    
      Los Angeles, California, United States, 90033
United States, Florida
Oncology-Hematology Group of South Florida    
      Miami, Florida, United States, 33176
The Center for Hematology-Oncology    
      Boca Raton, Florida, United States, 33486
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


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

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

Study placed in the following topic categories:
Lymphatic Diseases
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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