Combination Chemotherapy Followed by Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma

This study has been withdrawn prior to enrollment.
(Drug supply unavailable)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00310128
First received: March 29, 2006
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
AIDS-related Lymphoma
Adult Non-Hodgkin's Lymphoma
Anaplastic Large Cell Lymphoma
Drug: cisplatin
Drug: cytarabine
Drug: etoposide
Drug: methylprednisolone
Drug: rituximab
Drug: yttrium Y 90 ibritumomab tiuxetan
Procedure: antibody therapy
Procedure: biological therapy
Procedure: chemotherapy
Procedure: monoclonal antibody therapy
Procedure: radiation therapy
Procedure: radioimmunotherapy
Procedure: radioisotope therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AIDS Malignancy Clinical Trials Consortium:

Enrollment: 0
Study Start Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310128

Sponsors and Collaborators
AIDS Malignancy Clinical Trials Consortium
Investigators
Study Chair: Alexandra M. Levine, MD University of Southern California
Investigator: Anil Tulpule, MD University of Southern California
  More Information

No publications provided

Responsible Party: AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT00310128     History of Changes
Other Study ID Numbers: CDR0000467797, AMC-044
Study First Received: March 29, 2006
Last Updated: January 18, 2013
Health Authority: United States: Federal Government

Keywords provided by AIDS Malignancy Clinical Trials Consortium:
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
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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, Large-Cell, Anaplastic
Lymphoma, AIDS-Related
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Lymphoma, B-Cell
Rituximab
Cisplatin
Etoposide
Cytarabine
Methylprednisolone Hemisuccinate
Prednisolone
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 30, 2014