Lymphoma Clinical Trial
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
Verified date | August 2020 |
Source | AIDS Malignancy Consortium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | November 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory Winship Cancer Institute | Atlanta | Georgia |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Northwestern Cancer Center | Chicago | Illinois |
United States | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Baylor College of Medicine | Houston | Texas |
United States | Thomas Street Health Center | Houston | Texas |
United States | Rebecca and John Moores UCSD Cancer Center | La Jolla | California |
United States | UCLA Clinical AIDS Research and Education (CARE) Center | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia | Philadelphia | Pennsylvania |
United States | University of California at Davis Center for Aids Research and Education Services | Sacramento | California |
United States | Virginia Mason Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
AIDS Malignancy Consortium | National Cancer Institute (NCI), The Emmes Company, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose of bortezomib | Assessed at end of cycle 1 for each group of 3 subjects | ||
Primary | Overall lymphoma response rate | End of treatment | ||
Primary | Safety as assessed using the CTCAE | Every cycle of treatment and all post-treatment visits | ||
Secondary | Median overall survival at 1 year | 1 year post-treatment | ||
Secondary | Impact of bortezomib alone and in combination with rituximab, ifosfamide, carboplatin, and etoposide ([R]ICE) on serum HIV viral loads and APOBEC3G levels | baseline, day 2, 4, and 8 of week 1 of Part A, end of treatment | ||
Secondary | Impact of bortezomib alone and in combination with (R)ICE on EBV and HHV-8 lytic activation using serum viral loads | baseline, day 2, 4, and 8 of week 1 of Part A, end of treatment | ||
Secondary | Safety of bortezomib alone in patients with relapsed or refractory AIDS-associated lymphomas | Every cycle of treatment and all post-treatment visits | ||
Secondary | Correlation of EBV/HHV-8 viral load changes with lymphoma response | baseline, day 2, 4, and 8 of week 1 of Part A, end of treatment | ||
Secondary | 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 | Upon availability of both studies' results |
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