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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

NCT00070018 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-01-11

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Thomas P. Miller, MD · University of Arizona

  • Oliver W. Press, MD, PhD · Fred Hutchinson Cancer Center

  • Baldassarre D. Stea, MD, PhD · University of Arizona

  • Louis S. Constine, MD · James P. Wilmot Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2010-11-30
Completion
2015-01-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00070018 on ClinicalTrials.gov