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Bortezomib, Ifosfamide, Carboplatin, and Etoposide, With or Without Rituximab, in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rituximab
bortezomib
carboplatin
dexamethasone
etoposide
ifosfamide
polymerase chain reaction
western blotting
Sponsored by
AIDS Malignancy Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring AIDS-related diffuse large cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related lymphoblastic lymphoma, AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, AIDS-related small noncleaved cell lymphoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed relapsed or refractory HIV-associated non-Hodgkin lymphoma (NHL)

    • Must have histologic or cytologic documentation of prior AIDS-associated NHL (i.e., at time of diagnosis) for clinically relapsed and/or refractory disease for which biopsy is not feasible
    • Must have documented HIV seropositivity
    • Must have documentation of Epstein-Barr Virus (EBV)- and/or human herpes virus-8 (HHV-8)- positive infection within the lymphoma (i.e., LMP-1, LANA expression, or positive Epstein-Barr-encoded RNAs [EBERs])

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100%
  • Life expectancy > 2 months
  • ANC ≥ 1,000/mm³* (growth factor support allowed)
  • Hemoglobin ≥ 8.0 g/dL* (growth factor support allowed)
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 mg/dL
  • AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN)
  • Serum creatinine ≤ ULN
  • Creatinine clearance ≥ 50 mL/min
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception NOTE: *Patients with lymphomatous involvement of the bone unable to meet hematologic criteria are allowed

Exclusion criteria:

  • Peripheral neuropathy ≥ grade 2
  • Uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection

      • Opportunistic infections controlled by antimicrobial or suppressive therapy allowed, unless the investigator judges the infection likely to become life-threatening in the setting of multi-agent chemotherapy
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • NYHA class III or IV heat failure
    • Myocardial infarction within the past 6 months
    • Uncontrolled angina
    • Severe uncontrolled ventricular or other cardiac arrhythmias
    • Acute ischemia or active conduction system abnormalities by ECG
    • Serious psychiatric or medical illness, that would interfere with study compliance
  • Social situations that would interfere with study compliance
  • Acute active HIV-associated opportunistic infection requiring antibiotic treatment

    • Mycobacterium avium or candidiasis allowed unless concurrent therapy with moderate-to-strong CYP3A4 inducers or inhibitors is required
    • Chronic myelosuppressive agent therapy allowed provided hematologic criteria are met
  • Hypersensitivity to compounds of similar chemical or biological composition to bortezomib, boron, mannitol, ifosfamide, carboplatin, or etoposide
  • Concurrent malignancy except carcinoma in situ of the cervix, in situ anal cancer, nonmetastatic nonmelanoma skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy
  • Active hepatitis B infection (hepatitis B surface antigen-positive), unless 1 of the following criteria are met:

    • Able to start dual anti-hepatitis B adefovir and telbivudine therapy prior to study
    • Receiving dual anti-hepatitis B therapy for at least 12 weeks prior to study with either agent active against HIV (i.e., entecavir, tenofovir, lamivudine, or emtricitabine)
  • Concurrent grapefruit juice/fruit or green tea

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior adverse effects due to agents administered more than 3 weeks earlier
  • Glucocorticoid therapy within the past 3 weeks allowed
  • More than 3 weeks since prior chemotherapy
  • More than 2 weeks since prior radiotherapy
  • More than 14 days since prior and no other concurrent investigational agents (other than bortezomib)
  • No concurrent moderate-to-strong CYP3A4 inducers or inhibitors other than protease inhibitors
  • Concurrent stable (at least 12 weeks) antiretroviral regimen allowed

Sites / Locations

  • Rebecca and John Moores UCSD Cancer Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • UCLA Clinical AIDS Research and Education (CARE) Center
  • University of California at Davis Center for Aids Research and Education Services
  • University of Miami Sylvester Comprehensive Cancer Center - Miami
  • Emory Winship Cancer Institute
  • Cancer Research Center of Hawaii
  • Northwestern Cancer Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Beth Israel Deaconess Medical Center
  • Montefiore Medical Center
  • Memorial Sloan-Kettering Cancer Center
  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
  • Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
  • Thomas Street Health Center
  • Baylor College of Medicine
  • Virginia Mason Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CD20+ Non-Hodgkin Lymphoma

CD20- Non-Hodgkin Lymphoma

Arm Description

Part A: Velcade Day 1 and Day 8, with inter-subject dose escalation over four dose levels: 0.7 mg/m2, 1 mg/m2, 1.3 mg/m2 and 1.5 mg/m2. Dexamethasone 20 mg IV and etoposide 100 mg/m2 IV Days 8-10, carboplatin dosed to AUC=5 (maximum 750 mg) IV and ifosfamide 5000 mg/m2 mixed with an equal amount of Mesna on Day 9 of a 28-day cycle. Part B: Velcade on Days 1 and 8, dexamethasone 20 mg IV Days 1-3 and Day 8; etoposide 100 mg/m2 IV on Days 1-3; carboplatin dosed to AUC=5 (maximum 750 mg) IV on Day 2; ifosfamide 5000 mg/m2 mixed with an equal amount of Mesna and administered as a continuous IV infusion over 24 hours on Day 2, rituximab 375mg/m2 on Day 1 of a 21-day cycle.

Part A: Velcade Day 1 and Day 8, with inter-subject dose escalation over four dose levels: 0.7 mg/m2, 1 mg/m2, 1.3 mg/m2 and 1.5 mg/m2. Dexamethasone 20 mg IV and etoposide 100 mg/m2 IV Days 8-10, carboplatin dosed to AUC=5 (maximum 750 mg) IV and ifosfamide 5000 mg/m2 mixed with an equal amount of Mesna on Day 9 of a 28-day cycle. Part B: Velcade on Days 1 and 8, dexamethasone 20 mg IV Days 1-3 and Day 8; etoposide 100 mg/m2 IV on Days 1-3; carboplatin dosed to AUC=5 (maximum 750 mg) IV on Day 2; ifosfamide 5000 mg/m2 mixed with an equal amount of Mesna and administered as a continuous IV infusion over 24 hours on Day 2, 21-day cycle.

Outcomes

Primary Outcome Measures

Maximum tolerated dose of bortezomib
Overall lymphoma response rate
Safety as assessed using the CTCAE

Secondary Outcome Measures

Median overall survival at 1 year
Impact of bortezomib alone and in combination with rituximab, ifosfamide, carboplatin, and etoposide ([R]ICE) on serum HIV viral loads and APOBEC3G levels
Impact of bortezomib alone and in combination with (R)ICE on EBV and HHV-8 lytic activation using serum viral loads
Safety of bortezomib alone in patients with relapsed or refractory AIDS-associated lymphomas
Correlation of EBV/HHV-8 viral load changes with lymphoma response
Comparison of above outcomes to a parallel protocol employing ICE +/- rituximab in patients with EBV/HHV-8-negative AIDS-NHL to assess whether bortezomib has additional effects beyond (R)ICE alone

Full Information

First Posted
January 9, 2008
Last Updated
August 7, 2020
Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI), The Emmes Company, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00598169
Brief Title
Bortezomib, Ifosfamide, Carboplatin, and Etoposide, With or Without Rituximab, in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin Lymphoma
Official Title
Safety and Efficacy Pilot Trial of the Anti-Viral and Anti-Tumor Activity of Velcade Combined With (R)ICE in Subjects With EBV and/or HHV-8 Positive Relapsed/Refractory AIDS-Associated Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI), The Emmes Company, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving bortezomib together with combination chemotherapy is more effective with or without rituximab in treating AIDS-related non-Hodgkin lymphoma. PURPOSE: This clinical trial is studying giving bortezomib together with dexamethasone, ifosfamide, carboplatin, and etoposide to see how well it works with or without rituximab in treating patients with relapsed or refractory AIDS-related non-Hodgkin lymphoma.
Detailed Description
OBJECTIVES: Primary Evaluate the safety and overall lymphoma response rate of bortezomib in combination with ifosfamide, carboplatin, and etoposide (ICE) with or without rituximab in patients with Epstein-Barr Virus (EBV)- and/or human herpes virus-8 (HHV-8)- positive relapsed or refractory HIV-associated non-Hodgkin lymphoma (NHL). Secondary Evaluate the impact of bortezomib alone and in combination with rituximab) and ICE ([R] ICE) on serum HIV viral loads and APOBEC3G levels. Estimate the impact of bortezomib alone and in combination with (R)ICE on EBV and HHV-8 lytic activation using serum viral loads. Estimate the median response duration and 1 year overall survival rate of patients treated with this regimen. Evaluate the safety of bortezomib alone in patients with relapsed or refractory AIDS-associated lymphomas. Correlate EBV/HHV-8 viral load changes with lymphoma response. Compare the above outcomes to a parallel protocol employing ICE with or without rituximab in patients with EBV/HHV-8-negative AIDS-NHL to assess whether bortezomib has additional effects beyond (R)ICE alone. OUTLINE: This is a multicenter, dose-escalation study of bortezomib. Patients are assigned to 1 of 2 treatment groups. CD20-negative patients Part A: Patients receive bortezomib IV over 3-5 seconds on days 1 and 8, dexamethasone IV and etoposide IV over 2 hours on days 8-10, and ifosfamide IV continuously over 24-hours and carboplatin IV over 2 hours on day 9. Treatment repeats every 28 days until the maximum tolerated dose (MTD) is determined. Patients who tolerate the MTD of bortezomib may move on to part B. Part B: Patients receive bortezomib IV over 3-5 seconds at the MTD on days 1 and 8, dexamethasone IV on days 1-3 and 8, etoposide IV over 2 hours on days 1-3, and ifosfamide IV continuously over 24-hours and carboplatin IV over 2 hours on day 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Some patients may undergo hematopoietic stem cell transplantation (HSCT). CD20-positive patients Part A: Patients receive bortezomib, dexamethasone, etoposide, ifosfamide, and carboplatin as in the CD20-negative patients part A group. Part B: Patients receive rituximab IV on day 1. Patients also receive bortezomib, dexamethasone, etoposide, ifosfamide, and carboplatin as in the CD20-negative patients part B group. Some patients may undergo HSCT. Patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for the effects of bortezomib on viral activation and replication via Taqman polymerase chain reaction (PCR), and for quantification of APOBEC3G levels via western blot. Similar studies are performed on the BCLB-1 EBV containing lines, as well as Daudi and other EBV-transformed B-lymphocyte lines via quantitative viral DNA PCR. Patients complete the Functional Assessment of Cancer Therapy/GOG-Neurotoxicity Questionnaire, v4.0 at day 8 and week 4 of Part A and at least once per course of Part B for assessment of neuropathic pain and/or peripheral neuropathy. After completion of study treatment, patients achieving complete response (CR) are followed at 2-4 weeks and then every 3 months for 1 year. Patients not achieving CR at completion of study treatment and declining further antineoplastic treatment are followed at 2-4 weeks and then every 3 months for 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
AIDS-related diffuse large cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related lymphoblastic lymphoma, AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, AIDS-related small noncleaved cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD20+ Non-Hodgkin Lymphoma
Arm Type
Experimental
Arm Description
Part A: Velcade Day 1 and Day 8, with inter-subject dose escalation over four dose levels: 0.7 mg/m2, 1 mg/m2, 1.3 mg/m2 and 1.5 mg/m2. Dexamethasone 20 mg IV and etoposide 100 mg/m2 IV Days 8-10, carboplatin dosed to AUC=5 (maximum 750 mg) IV and ifosfamide 5000 mg/m2 mixed with an equal amount of Mesna on Day 9 of a 28-day cycle. Part B: Velcade on Days 1 and 8, dexamethasone 20 mg IV Days 1-3 and Day 8; etoposide 100 mg/m2 IV on Days 1-3; carboplatin dosed to AUC=5 (maximum 750 mg) IV on Day 2; ifosfamide 5000 mg/m2 mixed with an equal amount of Mesna and administered as a continuous IV infusion over 24 hours on Day 2, rituximab 375mg/m2 on Day 1 of a 21-day cycle.
Arm Title
CD20- Non-Hodgkin Lymphoma
Arm Type
Experimental
Arm Description
Part A: Velcade Day 1 and Day 8, with inter-subject dose escalation over four dose levels: 0.7 mg/m2, 1 mg/m2, 1.3 mg/m2 and 1.5 mg/m2. Dexamethasone 20 mg IV and etoposide 100 mg/m2 IV Days 8-10, carboplatin dosed to AUC=5 (maximum 750 mg) IV and ifosfamide 5000 mg/m2 mixed with an equal amount of Mesna on Day 9 of a 28-day cycle. Part B: Velcade on Days 1 and 8, dexamethasone 20 mg IV Days 1-3 and Day 8; etoposide 100 mg/m2 IV on Days 1-3; carboplatin dosed to AUC=5 (maximum 750 mg) IV on Day 2; ifosfamide 5000 mg/m2 mixed with an equal amount of Mesna and administered as a continuous IV infusion over 24 hours on Day 2, 21-day cycle.
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Description
375mg/m2 on Day 1
Intervention Type
Drug
Intervention Name(s)
bortezomib
Intervention Description
Part A: Velcade Day 1 and Day 8 of a 28-day cycle, with inter-subject dose escalation over four dose levels: 0.7 mg/m2, 1 mg/m2, 1.3 mg/m2 and 1.5 mg/m2 Part B: Velcade on Days 1 and 8 of a 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
Carboplatin will be dosed to an AUC=5, calculated using the Calvert formula (5 x [creatinine clearance + 25]; the maximum dose of carboplatin is 750 mg. Part A: AUC=5 (maximum 750 mg) IV administered on Day 9. Part B: AUC=5 (maximum 750 mg) IV administered on Day 2.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
Part A: 20 mg IV on Days 8-10. Part B: 20 mg IV on Days 1-3 and on Day 8.
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
Part A: 100 mg/m2 IV Days 8-10. Part B: 100 mg/m2 IV daily on Days 1 to 3.
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Description
Part A: 5000 mg/m2 mixed with an equal amount of Mesna as a 24 hour continuous IV infusion on Day 9. Part B: 5000 mg/m2 mixed with an equal dose of Mesna administered via continuous infusion for 24 hours beginning on Day 2.
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Description
Correlate EBV/HHV-8 viral load changes with lymphoma response. HIV and EBV/HHV-8 viral loads will be assessed on baseline, day 2, 4, and 8 of week 1 of Part A.
Intervention Type
Genetic
Intervention Name(s)
western blotting
Intervention Description
Peripheral blood mononuclear cells will be collected at Day 1 prior to chemotherapy, Day 2, 4 and 8 (prior to chemotherapy) then weekly during Part A, just prior to each additional cycle of Part B and at treatment completion. Western blot using antibody specific for APOBEC3G and antibody against actin for internal control will be used to quantify APOBEC3G levels. Changes at will be compared with baseline using a paired t-test.
Primary Outcome Measure Information:
Title
Maximum tolerated dose of bortezomib
Time Frame
Assessed at end of cycle 1 for each group of 3 subjects
Title
Overall lymphoma response rate
Time Frame
End of treatment
Title
Safety as assessed using the CTCAE
Time Frame
Every cycle of treatment and all post-treatment visits
Secondary Outcome Measure Information:
Title
Median overall survival at 1 year
Time Frame
1 year post-treatment
Title
Impact of bortezomib alone and in combination with rituximab, ifosfamide, carboplatin, and etoposide ([R]ICE) on serum HIV viral loads and APOBEC3G levels
Time Frame
baseline, day 2, 4, and 8 of week 1 of Part A, end of treatment
Title
Impact of bortezomib alone and in combination with (R)ICE on EBV and HHV-8 lytic activation using serum viral loads
Time Frame
baseline, day 2, 4, and 8 of week 1 of Part A, end of treatment
Title
Safety of bortezomib alone in patients with relapsed or refractory AIDS-associated lymphomas
Time Frame
Every cycle of treatment and all post-treatment visits
Title
Correlation of EBV/HHV-8 viral load changes with lymphoma response
Time Frame
baseline, day 2, 4, and 8 of week 1 of Part A, end of treatment
Title
Comparison of above outcomes to a parallel protocol employing ICE +/- rituximab in patients with EBV/HHV-8-negative AIDS-NHL to assess whether bortezomib has additional effects beyond (R)ICE alone
Time Frame
Upon availability of both studies' results

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed relapsed or refractory HIV-associated non-Hodgkin lymphoma (NHL) Must have histologic or cytologic documentation of prior AIDS-associated NHL (i.e., at time of diagnosis) for clinically relapsed and/or refractory disease for which biopsy is not feasible Must have documented HIV seropositivity Must have documentation of Epstein-Barr Virus (EBV)- and/or human herpes virus-8 (HHV-8)- positive infection within the lymphoma (i.e., LMP-1, LANA expression, or positive Epstein-Barr-encoded RNAs [EBERs]) PATIENT CHARACTERISTICS: Inclusion criteria: ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100% Life expectancy > 2 months ANC ≥ 1,000/mm³* (growth factor support allowed) Hemoglobin ≥ 8.0 g/dL* (growth factor support allowed) Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 mg/dL AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN) Serum creatinine ≤ ULN Creatinine clearance ≥ 50 mL/min Negative pregnancy test Not pregnant or nursing Fertile patients must use effective contraception NOTE: *Patients with lymphomatous involvement of the bone unable to meet hematologic criteria are allowed Exclusion criteria: Peripheral neuropathy ≥ grade 2 Uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection Opportunistic infections controlled by antimicrobial or suppressive therapy allowed, unless the investigator judges the infection likely to become life-threatening in the setting of multi-agent chemotherapy Symptomatic congestive heart failure Unstable angina pectoris NYHA class III or IV heat failure Myocardial infarction within the past 6 months Uncontrolled angina Severe uncontrolled ventricular or other cardiac arrhythmias Acute ischemia or active conduction system abnormalities by ECG Serious psychiatric or medical illness, that would interfere with study compliance Social situations that would interfere with study compliance Acute active HIV-associated opportunistic infection requiring antibiotic treatment Mycobacterium avium or candidiasis allowed unless concurrent therapy with moderate-to-strong CYP3A4 inducers or inhibitors is required Chronic myelosuppressive agent therapy allowed provided hematologic criteria are met Hypersensitivity to compounds of similar chemical or biological composition to bortezomib, boron, mannitol, ifosfamide, carboplatin, or etoposide Concurrent malignancy except carcinoma in situ of the cervix, in situ anal cancer, nonmetastatic nonmelanoma skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy Active hepatitis B infection (hepatitis B surface antigen-positive), unless 1 of the following criteria are met: Able to start dual anti-hepatitis B adefovir and telbivudine therapy prior to study Receiving dual anti-hepatitis B therapy for at least 12 weeks prior to study with either agent active against HIV (i.e., entecavir, tenofovir, lamivudine, or emtricitabine) Concurrent grapefruit juice/fruit or green tea PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior adverse effects due to agents administered more than 3 weeks earlier Glucocorticoid therapy within the past 3 weeks allowed More than 3 weeks since prior chemotherapy More than 2 weeks since prior radiotherapy More than 14 days since prior and no other concurrent investigational agents (other than bortezomib) No concurrent moderate-to-strong CYP3A4 inducers or inhibitors other than protease inhibitors Concurrent stable (at least 12 weeks) antiretroviral regimen allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin G. Reid, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
William Wachsman, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
UCLA Clinical AIDS Research and Education (CARE) Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1793
Country
United States
Facility Name
University of California at Davis Center for Aids Research and Education Services
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Northwestern Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Thomas Street Health Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2707
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30573564
Citation
Reid EG, Looney D, Maldarelli F, Noy A, Henry D, Aboulafia D, Ramos JC, Sparano J, Ambinder RF, Lee J, Cesarman E, Yahyaei S, Mitsuyasu R, Wachsman W; AIDS Malignancy Consortium. Safety and efficacy of an oncolytic viral strategy using bortezomib with ICE/R in relapsed/refractory HIV-positive lymphomas. Blood Adv. 2018 Dec 26;2(24):3618-3626. doi: 10.1182/bloodadvances.2018022095.
Results Reference
derived

Learn more about this trial

Bortezomib, Ifosfamide, Carboplatin, and Etoposide, With or Without Rituximab, in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin Lymphoma

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