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

This study has been terminated.
(Insufficient Accrual)
Sponsor:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00183976
First received: September 12, 2005
Last updated: May 20, 2014
Last verified: May 2006
  Purpose

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


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Burkitt Lymphoma
Primary Effusion Lymphomas
Drug: Pegylated Liposomal Doxorubicin (Doxil) and Rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Phase II Study of Pegylated Liposomal Doxorubicin (Doxil) With Rituximab in Relapsed AIDS-Related Non-Hodgkin's Lymphomas

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Estimated Enrollment: 15
Study Start Date: April 2005
Study Completion Date: January 2006
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183976

Locations
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Anil Tulpule, MD University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00183976     History of Changes
Other Study ID Numbers: 17NHL-03-2
Study First Received: September 12, 2005
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Diffuse mixed NHL
Diffuse or follicular large B-cell NHL
Immunoblastic NHL
Burkitt or Burkitt-like lymphomas

Additional relevant MeSH terms:
Burkitt Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Primary Effusion
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neoplasms by Histologic Type
Neoplasms
Lymphoma, B-Cell
Neoplasms, Experimental
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Liposomal doxorubicin
Rituximab
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 15, 2014