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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061672
• Other study ID #: M02-457
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2003
• Last updated: August 13, 2007
• Start date: April 2003

Study information

• Verified date: August 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• ABT-510 - Thrombospondin-1 Mimetic

Locations

Country	Name	City	State
United States	Albany Regional Cancer Center	Albany	New York
United States	The Center for Hematology-Oncology	Boca Raton	Florida
United States	Raleigh Hematology Oncology Clinic	Cary	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	Kansas City Oncology and Hematology Group	Kansas City	Missouri
United States	USC - Norris Cancer Center	Los Angeles	California
United States	U of W - Comprehensive Care Center	Madison	Wisconsin
United States	The West Cancer Clinic	Memphis	Tennessee
United States	Oncology-Hematology Group of South Florida	Miami	Florida
United States	Cancer Centers of Florida, P.A.	Orlando	Florida
United States	Hematology Oncology Associates	Phoenix	Arizona
United States	Hematology Oncology Associates	San Antonio	Texas
United States	Arch Medical Services, INC.	St. Louis	Missouri
United States	Arizona Clinical Research Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		One year
Secondary	Progression free survival		One year
Secondary	Overall survival		One year
Secondary	Performance status		One year