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AzTrials

LymphomaPhase 2NCT00070018

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

A Phase 2 study testing rituximab, Cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by SWOG Cancer Research Network at 48 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
rituximab, Cyclophosphamide and doxorubicin hydrochloride
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
48 sitesUnited States
Study dates
Feb 2004to 8 Jan 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 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)
  • 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
  • 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

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

United States48 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Community Oncology Group at Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Hackley Hospital

    Muskegon, Michigan, 49442

  • Edward Hospital Cancer Center

    Naperville, Illinois, 60540

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • Providence Cancer Institute at Providence Hospital - Southfield Campus

    Southfield, Michigan, 48075

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

  • Metro Health Hospital

    Wyoming, Michigan, 49519

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Conditions
Lymphoma
Keywords
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
Medical subject headings
Lymphoma, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Burkitt Lymphoma, Lymphoma, Large-Cell, Anaplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00070018
Study groupRoleWhat they receive
CHOP + RT + ZevalinExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival

    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.

    Measured: at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2003 (estimated)
  2. Study startFeb 2004
  3. Primary completionNov 2010
  4. Study completion8 Jan 2015

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00070018
Sponsor's protocol ID
CDR0000329864
Other IDs
U10CA032102, S0313
Status last verified
Dec 2021
First submitted
3 Oct 2003
Last updated
11 Jan 2022
Data monitoring committee
No

Publications

  • 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.

  • Persky DO, Miller TP, Unger JM, Spier CM, Puvvada S, Stea BD, Press OW, Constine LS, Barton KP, Friedberg JW, LeBlanc M, Fisher RI. Ibritumomab consolidation after 3 cycles of CHOP plus radiotherapy in high-risk limited-stage aggressive B-cell lymphoma: SWOG S0313. Blood. 2015 Jan 8;125(2):236-41. doi: 10.1182/blood-2014-06-584623. Epub 2014 Nov 13.

    PubMed 25395425

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab, Cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by SWOG Cancer Research Network at 48 sites in United States.

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: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 3 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Progression-free Survival (time frame: at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00070018, which also lists 2 linked publications.

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 11 Jan 2022.

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