Clinical trial · Interventional
Bortezomib, Ifosfamide, Carboplatin, and Etoposide, With or Without Rituximab, in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
| western blotting | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CD20+ Non-Hodgkin Lymphoma
- 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.
- interventionNames
- Biological: rituximab
- Drug: bortezomib
- Drug: carboplatin
- Drug: dexamethasone
- Drug: etoposide
- Drug: ifosfamide
- Genetic: polymerase chain reaction
- Genetic: western blotting
- type
- EXPERIMENTAL
- label
- CD20- Non-Hodgkin Lymphoma
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 allowedReferences
Publications (1)
- DERIVEDReid 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. PMID 30573564