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EPOCH Chemotherapy Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
AIDS Related Lymphoma, Non Hodgkin's Lymphoma

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Trial Information

EPOCH Chemotherapy Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma


The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed
setting. There is no standard treatment, and the few small studies that have been conducted
have reported dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus
rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study
include toxicity and response. Progression-free and overall survival will be measured.
Tumors will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation,
c-myc and EBV when possible.

Inclusion Criteria


- INCLUSION CRITERIA:

Aggressive CD20 + NHL confirmed by Pathology, DCS.

HIV + serology.

All stages (I-IV) of disease.

NHL previously treated with up to two chemotherapy regimens and evaluable disease.

Age greater than or equal to 18 years.

Laboratory test: (Abnormalities are allowed if due to organ involvement by lymphoma).

Creatinine less than or equal to 1.7.

Bilirubin must be less than 2.0 mg/dl, or total bilirubin less than or equal to 3.7 mg/dl
with direct fraction less than or equal to 0.2 mg/dl and indirect fraction of less than or
equal 3.5 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 3 times ULN (AST and ALT less than or equal to 6 times
ULN for patients on hyperalimentation for whom these abnormalities are felt to be due to
the hyperalimentation).

ANC greater than or equal 1000/mm(3).

Platelets must be greater than or equal to 75,000/mm(3) (patients with ITP platelets
greater than or equal to 30,000/mm(3).

Signed informed consent and Durable Power of Attorney.

EXCLUSION CRITERIA:

Pregnancy or nursing.

History of clinical heart failure or symptomatic ischemic heart disease.

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

Concurrent anti-retroviral therapy during EPOCH therapy.

Primary CNS lymphoma.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Toxicity and activity of EPOCH during and at the completion of study treatment

Safety Issue:

Yes

Principal Investigator

Wyndham H Wilson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

970040

NCT ID:

NCT00001563

Start Date:

December 1996

Completion Date:

May 2005

Related Keywords:

  • AIDS Related Lymphoma
  • Non Hodgkin's Lymphoma
  • HIV Lymphoma
  • Interleukin-12
  • Cytokines
  • Immunomodulation
  • Therapy
  • Acquired Immunodeficiency Syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, AIDS-Related

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892