EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00006436
First received: November 3, 2000
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

Background:

  • HIV-infected patients have a weakened immune system, and chemotherapy, which is used to treat lymphoma, probably causes further damage to the immune system.
  • Limiting the amount of immune damage due to chemotherapy might decrease the number of infections and the risk of developing cancer in the future in HIV-infected patients with non-Hodgkin's lymphoma.

Objectives:

  • To determine whether reducing the total amount of chemotherapy using a specific combination of drugs called EPOCH-R (etoposide, doxorubicin, vincristine, cyclophosphamide and rituximab) will rid the body of lymphoma quickly while decreasing the risk of infections and future cancers.
  • To determine whether the lymphoma will remain undetectable for at least one year if treatment is stopped one cycle after the patient enters remission.

Eligibility:

-Patients with non-Hodgkin's lymphoma and HIV infection 4 years of age and older who have not been treated previously with rituximab or cytotoxic chemotherapy.

Design:

  • Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than six cycles.
  • The lymphoma is evaluated using CT and PET scans at the end of treatment cycles 2 and 3. A bone marrow biopsy is repeated after cycle 2 if a biopsy was initially positive on screening for participation in the study.
  • Anti-HIV therapy is stopped before chemotherapy begins and is restarted when EPOCH-R treatment ends.
  • Patients are monitored for treatment response with blood tests and imaging scans at baseline, when treatment ends, 2 months after treatment ends and then every 3 to 6 months for a total of 24 months following chemotherapy.

Condition Intervention Phase
Lymphoma, AIDS-related
Lymphoma, Large B-cell, Diffuse
Biological: Rituximab
Biological: filgrastim
Drug: EPOCH
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short-Course EPOCH-Rituximab for Untreated CD-20+ HIV-Associated Lymphomas

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Progression-free survival at 1 year after completion of study treatment [ Time Frame: Time of progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity during and 1 year after completion of study treatment. [ Designated as safety issue: Yes ]
  • Response rate and duration at completion of study treatment and 5 years later. [ Designated as safety issue: No ]
  • Ability of positron emission tomography (PET) scans to predict freedom from relapse at completion of study treatment and 5 years later. [ Designated as safety issue: No ]
  • Effects of short course etoposide, vincristine, cyclophosphamide, doxorubicin, and rituximab (SC-EPOCH-R) on CD4 cell depletion and recovery at completion of study treatment and 18 months later. [ Designated as safety issue: No ]
  • Response to antiretroviral therapy following SC-EPOCH-R 18 months after completion of study treatment. [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2000
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Combo chemo and biological therapy
Biological: Rituximab
2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Biological: filgrastim
Figrastim day 6 until ANC reaches 5000 after the nadir, every cycle
Drug: EPOCH
combination chemotheray: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Aggressive CD20 positive Diffuse Large B-cell lymphoma confirmed by Laboratory of Pathology, NCI.

HIV + serology.

All stages (I-IV) of disease.

ECOG Performance status 0-4

NHL previously untreated with cytotoxic chemotherapy.

Age greater than or equal to 18 years

Laboratory tests (unless impairment due to respective organ involvement by tumor):

  • Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal to 50 ml/min
  • Bilirubin less than 2.0 mg/dl, or total bilirubin less than or equal to 4.5 mg/dl with direct fraction less than or equal to 0.3 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapy
  • AST and ALT less than or equal to 3x ULN (AST and ALT less than or equal to 6x ULN for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation)
  • ANC greater than or equal to 1000/mm(3)
  • Platelet greater than or equal to 75,000/mm(3) (unless impairment due to ITP)

Ability of patient to provide informed consent.

EXCLUSION CRITERIA:

Previous rituximab

Pregnancy or nursing.

  • Doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be excreted in milk.
  • Antiretroviral therapy is indicated during pregnancy and nursing.

Current clinical heart failure or symptomatic ischemic heart disease.

Serious underlying medical condition or infection other than HIV that would contraindicate SC-EPOCH-R.

  • Examples include, but are not limited to:
  • Severe AIDS-related wasting
  • Sever intractable diarrhea
  • Active inadequately treated opportunistic infection of the CNS

Concurrent anti-retroviral therapy during EPOCH therapy.

Primary CNS lymphoma.

  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: NCT00006436

Contacts
Contact: Margaret Shovlin, R.N. (301) 594-6597 mshovlin@mail.nih.gov
Contact: Wyndham H Wilson, M.D. (301) 435-2415 wilsonw@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Wyndham H Wilson, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT00006436     History of Changes
Obsolete Identifiers: NCT00020384
Other Study ID Numbers: 010030, 01-C-0030
Study First Received: November 3, 2000
Last Updated: September 26, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
AIDS
Malignancy
Antiretroviral
Chemotherapy
Monoclonal

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, AIDS-Related
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 30, 2014