Clinical trial NCT00061672: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Hodgkin's Lymphoma
Keywords: Non-Hodgkin's Lymphoma (NHL)
Hodgkin's Lymphoma (HL)
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-06-04
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Response rate
timeFrame: One year
Secondary outcomes:
measure: Progression free survival
timeFrame: One year
measure: Overall survival
timeFrame: One year
measure: Performance status
timeFrame: One year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hematology Oncology Associates
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Los Angeles
country: United States
facility: USC - Norris Cancer Center
state: California
city: Boca Raton
country: United States
facility: The Center for Hematology-Oncology
state: Florida
city: Miami
country: United States
facility: Oncology-Hematology Group of South Florida
state: Florida
city: Orlando
country: United States
facility: Cancer Centers of Florida, P.A.
state: Florida
city: Kansas City
country: United States
facility: Kansas City Oncology and Hematology Group
state: Missouri
city: St. Louis
country: United States
facility: Arch Medical Services, INC.
state: Missouri
city: Albany
country: United States
facility: Albany Regional Cancer Center
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Oncology Clinic
state: North Carolina
city: Memphis
country: United States
facility: The West Cancer Clinic
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Hematology Oncology Associates
state: Texas
city: Madison
country: United States
facility: U of W - Comprehensive Care Center
state: Wisconsin
Study officials:
affiliation: Abbott
name: Rod Humerickhouse, MD
role: STUDY_DIRECTOR
References: