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

Primary Purpose

Lymphoma, Non-Hodgkin, Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-510 - Thrombospondin-1 Mimetic
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Non-Hodgkin's Lymphoma (NHL), Hodgkin's Lymphoma (HL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hematology Oncology Associates
  • Arizona Clinical Research Center
  • USC - Norris Cancer Center
  • The Center for Hematology-Oncology
  • Oncology-Hematology Group of South Florida
  • Cancer Centers of Florida, P.A.
  • Kansas City Oncology and Hematology Group
  • Arch Medical Services, INC.
  • Albany Regional Cancer Center
  • Raleigh Hematology Oncology Clinic
  • The West Cancer Clinic
  • MD Anderson Cancer Center
  • Hematology Oncology Associates
  • U of W - Comprehensive Care Center

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Progression free survival
Overall survival
Performance status

Full Information

First Posted
June 2, 2003
Last Updated
August 13, 2007
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00061672
Brief Title
Study Evaluating the Safety and Effectiveness of ABT-510 in Subjects With Refractory Lymphoma
Official Title
A Phase II Study Evaluating the Safety and Effectiveness of ABT-510 in Subjects With Refractory Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, Hodgkin's Lymphoma
Keywords
Non-Hodgkin's Lymphoma (NHL), Hodgkin's Lymphoma (HL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ABT-510 - Thrombospondin-1 Mimetic
Primary Outcome Measure Information:
Title
Response rate
Time Frame
One year
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
One year
Title
Overall survival
Time Frame
One year
Title
Performance status
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rod Humerickhouse, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Hematology Oncology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
USC - Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
The Center for Hematology-Oncology
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Oncology-Hematology Group of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Cancer Centers of Florida, P.A.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Kansas City Oncology and Hematology Group
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Arch Medical Services, INC.
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63142
Country
United States
Facility Name
Albany Regional Cancer Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Raleigh Hematology Oncology Clinic
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
The West Cancer Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hematology Oncology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
U of W - Comprehensive Care Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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

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