Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT00598169
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00598169
Study Brief:
Protocol Section:
NCT00598169