Combination Chemotherapy Followed by Rituximab and Yttriu... | NCT00310128 | Trialant
NCT00310128
Sponsor
AIDS Malignancy Consortium
Status
Withdrawn
Last Update Posted
Feb 3, 2016Estimated
Enrollment
0Actual
Phase
Phase 2
Conditions
AIDS-related Lymphoma
Adult Non-Hodgkin's Lymphoma
Anaplastic Large Cell Lymphoma
Interventions
cisplatin
cytarabine
etoposide
methylprednisolone
rituximab
yttrium Y 90 ibritumomab tiuxetan
antibody therapy
biological therapy
chemotherapy
monoclonal antibody therapy
radiation therapy
radioimmunotherapy
radioisotope therapy
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00310128
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AMC-044
Secondary IDs
ID
Type
Description
Link
CDR0000467797
Other Identifier
NCI
Brief Title
Combination Chemotherapy Followed by Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma
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
Acronym
Not provided
Organization
AIDS Malignancy ConsortiumNETWORK
Status Module
Record Verification Date
Feb 2016
Overall Recruitment Status or Expanded Access Status
Withdrawn
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Drug supply unavailable
Expanded Access Info
No
Start Date
Feb 2006
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Mar 29, 2006
First Submission Date that Met QC Criteria
Mar 29, 2006
First Posted Date
Apr 3, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 1, 2016
Last Update Posted Date
Feb 3, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AIDS Malignancy ConsortiumNETWORK
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief 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. 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.
Conditions Module
Conditions
AIDS-related Lymphoma
Adult Non-Hodgkin's Lymphoma
Anaplastic Large Cell Lymphoma
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
0Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
cisplatin
Drug
cytarabine
Drug
etoposide
Drug
methylprednisolone
Drug
rituximab
Drug
yttrium Y 90 ibritumomab tiuxetan
Drug
antibody therapy
Procedure
biological therapy
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
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)
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Alexandra M. Levine, MD
University of Southern California
Study Chair
Anil Tulpule, MD
University of Southern California
Locations
Not provided
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
stage I adult Burkitt's lymphoma
stage III adult Burkitt's lymphoma
stage IV adult Burkitt's lymphoma
anaplastic large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
recurrent adult diffuse large cell lymphoma
stage I adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
recurrent adult diffuse mixed cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage IV adult diffuse mixed cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma