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EPOCH Chemotherapy +/- IL-12 for Previously Untreated and EPOCH Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma

Primary Purpose

AIDS Related Lymphoma, AIDS-Associated Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Filgrastim
Rituximab
EPOCH
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AIDS Related Lymphoma focused on measuring Lymphomagenesis, Molecular markers of drug resistance, Refractory, progressive, or relapsed HIV + NHL, AIDS-related NHL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

EPOCH-R every 3 weeks for up to 6 cycle

Outcomes

Primary Outcome Measures

Determination of safety profile and response rates
number and types of adverse events {AEs), as well as the number of patients who respond to the therapy {CR, PR, SD)

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
January 18, 2022
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001563
Brief Title
EPOCH Chemotherapy +/- IL-12 for Previously Untreated and EPOCH Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma
Official Title
EPOCH Chemotherapy Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 1997 (Actual)
Primary Completion Date
May 5, 2005 (Actual)
Study Completion Date
May 5, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS Related Lymphoma, AIDS-Associated Lymphoma
Keywords
Lymphomagenesis, Molecular markers of drug resistance, Refractory, progressive, or relapsed HIV + NHL, AIDS-related NHL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
EPOCH-R every 3 weeks for up to 6 cycle
Intervention Type
Biological
Intervention Name(s)
Filgrastim
Intervention Description
Filgrastim after EPOCH-R from Day 6 for 10 days every cycle.
Intervention Type
Biological
Intervention Name(s)
Rituximab
Intervention Description
EPOCH-R every 3 weeks for up to 6 cycle
Intervention Type
Drug
Intervention Name(s)
EPOCH
Intervention Description
EPOCH-R every 3 weeks for up to 6 cycle
Primary Outcome Measure Information:
Title
Determination of safety profile and response rates
Description
number and types of adverse events {AEs), as well as the number of patients who respond to the therapy {CR, PR, SD)
Time Frame
End of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wyndham H Wilson, M.D.
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2536124
Citation
Kaplan LD, Abrams DI, Feigal E, McGrath M, Kahn J, Neville P, Ziegler J, Volberding PA. AIDS-associated non-Hodgkin's lymphoma in San Francisco. JAMA. 1989 Feb 3;261(5):719-24.
Results Reference
background
PubMed Identifier
7950915
Citation
Sparano JA, Wiernik PH, Strack M, Leaf A, Becker NH, Sarta C, Carney D, Elkind R, Shah M, Valentine ES, et al. Infusional cyclophosphamide, doxorubicin and etoposide in HIV-related non-Hodgkin's lymphoma: a follow-up report of a highly active regimen. Leuk Lymphoma. 1994 Jul;14(3-4):263-71. doi: 10.3109/10428199409049677.
Results Reference
background
PubMed Identifier
1672911
Citation
Beral V, Peterman T, Berkelman R, Jaffe H. AIDS-associated non-Hodgkin lymphoma. Lancet. 1991 Apr 6;337(8745):805-9. doi: 10.1016/0140-6736(91)92513-2.
Results Reference
background
PubMed Identifier
30125215
Citation
Kurtz DM, Scherer F, Jin MC, Soo J, Craig AFM, Esfahani MS, Chabon JJ, Stehr H, Liu CL, Tibshirani R, Maeda LS, Gupta NK, Khodadoust MS, Advani RH, Levy R, Newman AM, Duhrsen U, Huttmann A, Meignan M, Casasnovas RO, Westin JR, Roschewski M, Wilson WH, Gaidano G, Rossi D, Diehn M, Alizadeh AA. Circulating Tumor DNA Measurements As Early Outcome Predictors in Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2018 Oct 1;36(28):2845-2853. doi: 10.1200/JCO.2018.78.5246. Epub 2018 Aug 20.
Results Reference
derived
PubMed Identifier
20130244
Citation
Dunleavy K, Little RF, Pittaluga S, Grant N, Wayne AS, Carrasquillo JA, Steinberg SM, Yarchoan R, Jaffe ES, Wilson WH. The role of tumor histogenesis, FDG-PET, and short-course EPOCH with dose-dense rituximab (SC-EPOCH-RR) in HIV-associated diffuse large B-cell lymphoma. Blood. 2010 Apr 15;115(15):3017-24. doi: 10.1182/blood-2009-11-253039. Epub 2010 Feb 3.
Results Reference
derived
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1997-C-0040.html
Description
NIH Clinical Center Detailed Web Page

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EPOCH Chemotherapy +/- IL-12 for Previously Untreated and EPOCH Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma

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