S0313 Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00070018 |
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Recruitment Status :
Completed
First Posted : October 7, 2003
Results First Posted : April 3, 2012
Last Update Posted : January 11, 2022
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Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
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Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining chemotherapy with radiation therapy and monoclonal antibody therapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy and monoclonal antibody therapy works in treating patients with stage I or stage II non-Hodgkin's lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: rituximab Drug: Cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy Biological: Yttrium-90 ibritumomab tiuxetan Biological: Indium-111 ibritumomab tiuxetan | Phase 2 |
OBJECTIVES:
- Determine the 2-year progression-free survival of patients with aggressive high-risk stage I or IE or non-bulky stage II or IIE CD20-positive non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone and radiotherapy followed by rituximab and yttrium Y 90 ibritumomab tiuxetan.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Chemotherapy: Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 1-2 hours, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
- Radiotherapy: Beginning 3 weeks after the completion of CHOP chemotherapy, patients undergo radiotherapy once daily 5 days a week for 4-5 weeks.
- Monoclonal antibody therapy: Beginning 3-6 weeks after the completion of radiotherapy, patients receive rituximab IV followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients then undergo whole body imaging. If ibritumomab tiuxetan biodistribution is acceptable, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7, 8, OR 9.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 15 months.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 46 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin Lymphoma, Phase II |
| Study Start Date : | February 2004 |
| Actual Primary Completion Date : | November 2010 |
| Actual Study Completion Date : | January 8, 2015 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: CHOP + RT + Zevalin
Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
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Biological: rituximab
250 mg/m^2, as part of Zevalin regimen Drug: Cyclophosphamide 750 mg/m^2 Drug: doxorubicin hydrochloride 50 mg/m^2 Drug: prednisone 100 mg Drug: vincristine sulfate 1.4 mg/m^2 Radiation: radiation therapy 4000-5000 cGy total Biological: Yttrium-90 ibritumomab tiuxetan 0.4 mCi/kg Biological: Indium-111 ibritumomab tiuxetan 5 mCi |
Primary Outcome Measures :
- Progression-free Survival [ Time Frame: at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter ]Measured from date of registration to date of first observation of progression or symptomatic deterioration. Progression is defined as one or more of the following must occur. Unequivocal progression of disease in the opinion of the treating physician (an explanation must be provided). Appearance of a new lesion/site. Death due to disease without documented progression or symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:
- Diffuse large B-cell
- Mantle cell
- High-grade B-cell, Burkitt's, or Burkitt-like
- Anaplastic large cell (B-cell phenotype only)
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Stage I, IE, or non-bulky* stage II or IIE disease by Ann Arbor classification
- Patients who have bulky stage II or IIE disease are ineligible even if, after resection, the measurements are less than 10.0 cm NOTE: *Non-bulky disease defined as any tumor measuring less than 10.0 cm or occupying less than 1/3 of the chest diameter
- CD20-expressing disease by flow cytometry or immunoperoxidase staining
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Aggressive lymphomas must have at least 1 of the following adverse prognostic factors:
- Non-bulky stage II or IIE disease
- At least 60 years of age
- Zubrod performance status of 2
- Lactic dehydrogenase greater than upper limit of normal
- All disease must be encompassable in a single radiation port (including any site of resected disease) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No medical contraindication to study chemotherapy, rituximab, or ibritumomab tiuxetan
- No known AIDS syndrome or HIV-associated complex
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior monoclonal antibody therapy
Chemotherapy
- No prior chemotherapy for lymphoma
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy for lymphoma
- No concurrent intensity-modulated radiotherapy
- Planned involved-field radiotherapy must not encompass more than 25% of active bone marrow space
Surgery
- See Disease Characteristics
Other
- Concurrent participation in SWOG-8947 or SWOG-8819 allowed
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070018
Locations
Show 48 study locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
| Study Chair: | Thomas P. Miller, MD | University of Arizona | |
| Study Chair: | Oliver W. Press, MD, PhD | Fred Hutchinson Cancer Research Center | |
| Study Chair: | Baldassarre D. Stea, MD, PhD | University of Arizona | |
| Study Chair: | Louis S. Constine, MD | James P. Wilmot Cancer Center |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Miller TP, Unger JM, Spier C, et al.: Effect of adding ibritumomab tiuxetan (Zevalin) radioimmunotherapy consolidation to three cycles of CHOP plus involved-field radiotherapy for limited-stage aggressive diffuse B-cell lymphoma (SWOG 0313). [Abstract] Blood 112 (11): A-3598, 2008.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00070018 |
| Other Study ID Numbers: |
CDR0000329864 U10CA032102 ( U.S. NIH Grant/Contract ) S0313 ( Other Identifier: SWOG ) |
| First Posted: | October 7, 2003 Key Record Dates |
| Results First Posted: | April 3, 2012 |
| Last Update Posted: | January 11, 2022 |
| Last Verified: | December 2021 |
Keywords provided by Southwest Oncology Group:
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stage I mantle cell lymphoma stage I adult diffuse large cell lymphoma stage I adult Burkitt lymphoma anaplastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma |
contiguous stage II adult Burkitt lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II mantle cell lymphoma |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisone Cyclophosphamide Rituximab Doxorubicin Liposomal doxorubicin Vincristine Antibodies, Monoclonal |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents |