Pegylated Liposomal Doxorubicin (Doxil) With Rituximab in Relapsed AIDS-Related Non-Hodgkin’s Lymphomas

Brief Title

Pegylated Liposomal Doxorubicin (Doxil) With Rituximab in Relapsed AIDS-Related Non-Hodgkin's Lymphomas

Official Title

A Pilot Phase II Study of Pegylated Liposomal Doxorubicin (Doxil) With Rituximab in Relapsed AIDS-Related Non-Hodgkin's Lymphomas

Brief Summary

      This study is for patients who have been treated before and either the treatment did not work
      or the lymphoma has come back.
    


Study Phase

Phase 2

Study Type

Interventional




Condition

Non-Hodgkin's Lymphoma

Intervention

Pegylated Liposomal Doxorubicin (Doxil) and Rituximab


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

15

Start Date

April 2005

Completion Date

January 2006

Primary Completion Date

September 2005

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically documented B-cell non-Hodgkin's lymphoma [NHL]
             (diffuse mixed, diffuse or follicular large B-cell, immunoblastic), Burkitt or
             Burkitt-like lymphomas, and primary effusion lymphomas.

          -  Seropositive for HIV by any approved test (prior documentation of HIV seropositivity
             is acceptable).

          -  Failed or relapsed after at least 1 prior chemotherapy treatment (chemotx) regimen but
             could have had no more than 2 prior chemotx regimens with only one of them being an
             anthracycline-containing regimen. Prior treatment (tx) with rituximab allowed.

          -  All stages of disease

          -  Measurable or evaluable tumor

          -  Greater than or equal to 18 years of age

          -  Karnofsky performance status greater than 50%

          -  Absolute granulocyte count (AGC) greater than 1.0; platelets greater than 75,000;
             hemoglobin (Hgb) greater than 8.0 (unless these parameters are abnormal secondary to
             lymphomatous involvement of marrow, or due to HIV-related thrombocytopenia).

          -  Bilirubin less than 2.0 (unless elevated secondary to lymphomatous involvement of
             liver or biliary system or due to other HIV-related medications such as Crixivan).

          -  Creatinine less than 2.5 or creatinine clearance greater than 60 ml/min

          -  Multigated acquisition (MUGA) scan or 2D echocardiogram indicating left ventricular
             ejection fraction (LVEF) greater than or equal to 50% within 42 days prior to first
             dose of study drug.

          -  Patients with central nervous system (CNS) involvement are eligible provided that
             systemic lymphomatous disease is also present.

          -  Concurrent therapy for HIV with any licensed agent or an agent available on an
             expanded access program will be required.

          -  Signed informed consent including Health Insurance Portability and Accountability Act
             of 1996 (HIPAA) authorization.

        Exclusion Criteria:

          -  Acute intercurrent infection that may interfere with planned protocol. Patients with
             mycobacterium avium are not excluded. Chronic therapy with potentially
             myelosuppressive agents is allowed provided that entry hematologic criteria are met.

          -  Second active tumor. Patients with non-melanomatous skin cancer, in-situ cervical
             cancer, or Kaposi's sarcoma, not requiring systemic chemotherapy may be entered on
             study.

          -  Primary CNS lymphoma.

          -  Documented history of congestive heart failure (CHF), hemodynamically unstable
             arrhythmia, myocardial infarction (MI) in the preceding 6 months, or evidence on
             electrocardiogram (EKG) of untreated cardiac ischemia.

          -  Prior exposure to a liposomal anthracycline (liposomal doxorubicin or daunorubicin)
             for the treatment of lymphoma. Prior exposure to conventional doxorubicin allowed.

          -  Prior radiation therapy within 4 weeks, unless for emergency conditions secondary to
             lymphoma (i.e., CNS tumor, cord compression)

          -  Prior systemic chemotherapy or biologic therapy within 3 weeks

          -  History of hypersensitivity reaction to anthracyclines or granulocyte
             colony-stimulating factor (G-CSF)

          -  History of hypersensitivity reactions attributed to a conventional formulation of
             doxorubicin hydrochloride (HCl)

          -  Investigational agent(s) within 4 weeks of start of study therapy.

          -  History of cardiac disease with New York Heart Association (NYHA) greater than or
             equal to Class II, or clinical evidence of CHF

          -  Pregnant or nursing mothers.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anil Tulpule, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00183976

Organization ID

17NHL-03-2


Responsible Party

Sponsor

Study Sponsor

University of Southern California


Study Sponsor

Anil Tulpule, MD, Principal Investigator, University of Southern California


Verification Date

May 2006