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

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

Sponsoren

Hauptsponsor: Abbott

Quelle Abbott
Kurze Zusammenfassung

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

Gesamtstatus Completed
Anfangsdatum April 2003
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Response rate One year
Sekundäres Ergebnis
Messen Zeitfenster
Progression free survival One year
Overall survival One year
Performance status One year
Einschreibung 67
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: ABT-510 - Thrombospondin-1 Mimetic

Teilnahmeberechtigung

Kriterien:

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.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Rod Humerickhouse, MD Study Director Abbott
Ort
Einrichtung:
Hematology Oncology Associates | Phoenix, Arizona, 85012, United States
Arizona Clinical Research Center | Tucson, Arizona, 85712, United States
USC - Norris Cancer Center | Los Angeles, California, 90033, United States
The Center for Hematology-Oncology | Boca Raton, Florida, 33486, United States
Oncology-Hematology Group of South Florida | Miami, Florida, 33176, United States
Cancer Centers of Florida, P.A. | Orlando, Florida, 32806, United States
Kansas City Oncology and Hematology Group | Kansas City, Missouri, 64111, United States
Arch Medical Services, INC. | St. Louis, Missouri, 63142, United States
Albany Regional Cancer Center | Albany, New York, 12208, United States
Raleigh Hematology Oncology Clinic | Cary, North Carolina, 27511, United States
The West Cancer Clinic | Memphis, Tennessee, 38120, United States
MD Anderson Cancer Center | Houston, Texas, 77030, United States
Hematology Oncology Associates | San Antonio, Texas, 78229, United States
U of W - Comprehensive Care Center | Madison, Wisconsin, 53792, United States
Standort Länder

United States

Überprüfungsdatum

August 2007

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov