AIDS-related LymphomaPhase 2NCT00310128
Combination Chemotherapy Followed by Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma
A Phase 2 study testing cisplatin, cytarabine and etoposide in people with AIDS-related Lymphoma and Adult Non-Hodgkin's Lymphoma, run by AIDS Malignancy Consortium.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as etoposide, methylprednisolone, cytarabine, and cisplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS-related Lymphoma, Adult Non-Hodgkin's Lymphoma, Anaplastic Large Cell Lymphoma
- What is being tested?
- cisplatin, cytarabine and etoposide
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically documented B-cell non-Hodgkin's lymphoma, including any of the following histologic types:
- Follicular large B-cell lymphoma (follicular, grade 3)
- Follicular mixed cell lymphoma (follicular, grade 2)
- Diffuse mixed cell lymphoma
- Diffuse large B-cell lymphoma
- Immunoblastic lymphoma
- Burkitt or Burkitt-like lymphoma
- Anaplastic large cell lymphoma
- Primary effusion lymphoma
- All stages eligible
- Seropositive for HIV by any approved test or positive HIV-1 RNA in plasma at anytime in the past
- Prior documentation of HIV seropositivity allowed
- Received 1 prior anthracycline-based regimen of curative intent
- No more than 1 prior regimen
- Measurable or evaluable disease
- Evaluable disease defined as not having bidimensional measurements (i.e., gastric or marrow involvement) but can be followed for response by other diagnostic tests, such as gallium scan, positron emission tomography (PET) imaging and/or bone marrow biopsy
- No primary CNS lymphoma
- Lymphomatous meningitis or brain metastasis eligible provided other measurable systemic lymphomatous disease is also present
- Less than 25% bone marrow involvement with lymphoma
- Concurrent effective highly active anti-retroviral therapy (HAART) required at study entry
- HIV viral load < 100,000 copies/mL if HAART was not used previously
PATIENT CHARACTERISTICS:
- Karnofsky performance status 50-100%
- Bilirubin ≤ 2.0 mg/dL (unless elevated due to lymphomatous involvement of the liver or biliary tract OR due to other HIV medications [e.g., indinavir or atazanavir])
- Creatinine < 2.0 mg/dL (< 2.6 mg/dL if due to use of tenofovir or truvada) OR creatinine clearance ≥ 60 mL/min
- Granulocyte count > 1,000/mm^3 (unless abnormal due to lymphomatous involvement of the bone marrow)
- Platelet count > 75,000/mm^3 (unless abnormal due to lymphomatous involvement of the bone marrow or HIV-related thrombocytopenia)
- No acute intercurrent infection that may interfere with study participation
- Mycobacterium avium allowed
- No second active tumor except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or Kaposi's sarcoma not requiring systemic chemotherapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
- No serious, ongoing nonmalignant disease or infection that would compromise study objectives
- No antimurine antibody (HAMA) reactivity
- No history of any cutaneous or mucocutaneous reaction from prior rituximab administration
- No history of cutaneous or mucocutaneous reactions or diseases severe enough to cause hospitalization or an inability to eat for ≥ 2 days
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Fully recovered from all toxicities associated with prior surgery, radiotherapy, chemotherapy, or immunotherapy
- Prior chronic therapy with potentially myelosuppressive agents allowed provided hematologic criteria are met at study entry
- No radiotherapy within the past 4 weeks, unless for emergency conditions secondary to lymphoma (i.e., cord compression)
- No anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C)
- No rituximab within 6 weeks before study radioimmunotherapy
- No investigational agent(s) within the past 4 weeks, unless these are antiretroviral agents available on a compassionate use basis
- No prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional)
- No major surgery, other than diagnostic surgery, within the past 4 weeks
- No prior myeloablative therapies with autologous bone marrow transplantation, peripheral blood stem cell rescue, or failed stem cell collection
- No prior radioimmunotherapy
- No pegfilgrastim within 4 weeks before study radioimmunotherapy
- No other growth factors within 2 weeks before and after study radioimmunotherapy
- No other concurrent myelosuppressive antineoplastic agents after receipt of study radioimmunotherapy until blood counts recover
- No zidovudine-containing regimens (including lamivudine and trizivir) during and for ≥ 2 months after completion of study radioimmunotherapy
About this study
Official title: Phase II Study of Induction Therapy Comprising Etoposide, Methylprednisolone, Cytarabine, and Cisplatin (ESHAP) Followed by Consolidation Therapy Comprising Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy, such as etoposide, methylprednisolone, cytarabine, and cisplatin, 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 and yttrium Y 90 ibritumomab tiuxetan, 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 without harming normal cells. Giving more than one drug (combination chemotherapy) together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed or refractory AIDS-related non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the overall survival rate at one year in patients with relapsed or refractory AIDS-related non-Hodgkin's lymphoma treated with consolidation therapy comprising rituximab and yttrium Y 90 ibritumomab tiuxetan (radioimmunotherapy) given after induction therapy comprising etoposide, methylprednisolone, cytarabine, and cisplatin (ESHAP).
- Describe the toxicity profile of radioimmunotherapy as consolidation therapy, including changes in immunologic and virologic parameters over time, in these patients.
- Determine the overall disease-free survival of patients receiving ESHAP as induction therapy followed by radioimmunotherapy as consolidation therapy.
Secondary
- Determine the effect of ESHAP as induction therapy and radioimmunotherapy as consolidation therapy on HIV-1 viral load, CD4 and CD8 cells, and quantitative immunoglobulin levels in patients on concurrent highly active antiretroviral therapy (HAART).
- Determine the objective response rates (complete and partial response) in patients treated with this regimen.
- Determine the toxicity of ESHAP as induction therapy in these patients.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive ESHAP chemotherapy comprising etoposide IV over 2 hours on days 1-4, methylprednisolone IV over 15-30 minutes on days 1-5, cisplatin IV continuously over 96 hours on days 1-4, and cytarabine IV over 2 hours on day 5. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Approximately 21-52 days after completion of ESHAP chemotherapy, patients proceed to consolidation therapy.
- Consolidation therapy: Patients receive radioimmunotherapy comprising rituximab IV over 3-4 hours followed by indium In 111 ibritumomab tiuxetan (for radioimaging) IV over 10 minutes on day 1. Patients then undergo imaging on days 1 and 2. If biodistribution is acceptable, patients receive rituximab IV over 3-4 hours followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
After completing study treatment, patients are followed every 2 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
- Being tested
- cisplatin, cytarabine, etoposide, methylprednisolone, rituximab
- Keywords
- AIDS-related diffuse large cell lymphoma, AIDS-related peripheral/systemic lymphoma, AIDS-related small noncleaved cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related immunoblastic large cell lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II adult Burkitt's lymphoma, noncontiguous stage II adult Burkitt's lymphoma, recurrent adult Burkitt's lymphoma
- Medical subject headings
- Lymphoma, AIDS-Related, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Follicular, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
cytarabineDrug
etoposideDrug
rituximabDrug
yttrium Y 90 ibritumomab tiuxetanDrug
antibody therapyProcedure or surgery
biological therapyProcedure or surgery
chemotherapyProcedure or surgery
monoclonal antibody therapyProcedure or surgery
radiation therapyProcedure or surgery
radioimmunotherapyProcedure or surgery
radioisotope therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startFeb 2006
Why it stopped: Drug supply unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS-related LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alexandra M. Levine, MD, Study chair, University of Southern CaliforniaAnil Tulpule, MD, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310128
- Sponsor's protocol ID
- AMC-044
- Other IDs
- CDR0000467797
- Status last verified
- Feb 2016
- First submitted
- 29 Mar 2006
- Last updated
- 3 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Induction Therapy Comprising Etoposide, Methylprednisolone, Cytarabine, and Cisplatin (ESHAP) Followed by Consolidation Therapy Comprising Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00310128
- Acronym / sponsor ID
- AMC-044
- Keywords
- AIDS-related diffuse large cell lymphoma, AIDS-related peripheral/systemic lymphoma, AIDS-related small noncleaved cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related immunoblastic large cell lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drug supply unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2006
- First posted
- 3 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as etoposide, methylprednisolone, cytarabine, and cisplatin, 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 and yttrium Y 90 ibritumomab tiuxetan, 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 without harming normal cells. Giving more than one drug (combination chemotherapy) together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed or refractory AIDS-related non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the overall survival rate at one year in patients with relapsed or refractory AIDS-related non-Hodgkin's lymphoma treated with consolidation therapy comprising rituximab and yttrium Y 90 ibritumomab tiuxetan (radioimmunotherapy) given after induction therapy comprising etoposide, methylprednisolone, cytarabine, and cisplatin (ESHAP).
- Describe the toxicity profile of radioimmunotherapy as consolidation therapy, including changes in immunologic and virologic parameters over time, in these patients.
- Determine the overall disease-free survival of patients receiving ESHAP as induction therapy followed by radioimmunotherapy as consolidation therapy.
Secondary
- Determine the effect of ESHAP as induction therapy and radioimmunotherapy as consolidation therapy on HIV-1 viral load, CD4 and CD8 cells, and quantitative immunoglobulin levels in patients on concurrent highly active antiretroviral therapy (HAART).
- Determine the objective response rates (complete and partial response) in patients treated with this regimen.
- Determine the toxicity of ESHAP as induction therapy in these patients.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive ESHAP chemotherapy comprising etoposide IV over 2 hours on days 1-4, methylprednisolone IV over 15-30 minutes on days 1-5, cisplatin IV continuously over 96 hours on days 1-4, and cytarabine IV over 2 hours on day 5. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Approximately 21-52 days after completion of ESHAP chemotherapy, patients proceed to consolidation therapy.
- Consolidation therapy: Patients receive radioimmunotherapy comprising rituximab IV over 3-4 hours followed by indium In 111 ibritumomab tiuxetan (for radioimaging) IV over 10 minutes on day 1. Patients then undergo imaging on days 1 and 2. If biodistribution is acceptable, patients receive rituximab IV over 3-4 hours followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
After completing study treatment, patients are followed every 2 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin | Drug | – |
| cytarabine | Drug | – |
| etoposide | Drug | – |
| methylprednisolone | Drug | – |
| rituximab | Drug | – |
| yttrium Y 90 ibritumomab tiuxetan | Drug | – |
| antibody therapy | Procedure or surgery | – |
| biological therapy | Procedure or surgery | – |
| chemotherapy | Procedure or surgery | – |
| monoclonal antibody therapy | Procedure or surgery | – |
| radiation therapy | Procedure or surgery | – |
| radioimmunotherapy | Procedure or surgery | – |
| radioisotope therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra M. Levine, MD study chair
University of Southern California
Anil Tulpule, MD
University of Southern California
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, cytarabine and etoposide in people with AIDS-related Lymphoma and Adult Non-Hodgkin's Lymphoma, run by AIDS Malignancy Consortium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.