Burkitt's lymphoma

Sponsored by: Abbott Laboratories

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

Study Type: Interventional

Study Design: Treatment

Ages eligible for study: 18 years and above, both genders

Inclusion Criteria:

* 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 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 received no more than five prior therapies for lymphoma.

* 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/[mm.sup.3]; Platelets greater than or equal to 75,000/[mm.sup.3]; Hemoglobin greater than or equal to 8.5 g/dL; ANC greater than or equal to 1000/[mm.sup.3] * 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 known Central Nervous System (CNS) metastasis.

* Brain CT within 28 days of enrollment is required to confirm absence of CNS metastases.

* Subjects with previously treated brain metastases are eligible if no evidence of disease is observed on CT.

* 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 is receiving therapeutic anticoagulation therapy.

* Low dose anticoagulation for a catheter prophylaxis is permitted; PT/PTT must be within normal limits.

* 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.

* Subject has history of other previous malignancies within 5 years, with the exception of:

* Adequately treated in situ carcinoma of the cervix uteri; * Basal or squamous cell carcinoma of the skin.

Location and Contact Information:

Ray Knight, BS MBA Tel: 847-938-1378 E-mail: raymond.knight@abbott.com Alexandria Levine, MD, Principal Investigator

California

Study ID Numbers M02-457

NLM Identifier NCT00061672

COPYRIGHT 2003 Journal of Drugs in Dermatology
COPYRIGHT 2003 Gale Group