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

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00061672

Collaborator

(none)

Enrollment

Locations

4.8

Patients Per Site

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2003

Outcome Measures

Primary Outcome Measures

Response rate [One year]

Secondary Outcome Measures

Progression free survival [One year]
Overall survival [One year]
Performance status [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology Oncology Associates	Phoenix	Arizona	United States	85012
2	Arizona Clinical Research Center	Tucson	Arizona	United States	85712
3	USC - Norris Cancer Center	Los Angeles	California	United States	90033
4	The Center for Hematology-Oncology	Boca Raton	Florida	United States	33486
5	Oncology-Hematology Group of South Florida	Miami	Florida	United States	33176
6	Cancer Centers of Florida, P.A.	Orlando	Florida	United States	32806
7	Kansas City Oncology and Hematology Group	Kansas City	Missouri	United States	64111
8	Arch Medical Services, INC.	St. Louis	Missouri	United States	63142
9	Albany Regional Cancer Center	Albany	New York	United States	12208
10	Raleigh Hematology Oncology Clinic	Cary	North Carolina	United States	27511
11	The West Cancer Clinic	Memphis	Tennessee	United States	38120
12	MD Anderson Cancer Center	Houston	Texas	United States	77030
13	Hematology Oncology Associates	San Antonio	Texas	United States	78229
14	U of W - Comprehensive Care Center	Madison	Wisconsin	United States	53792