Find a Trial Find Expert Physicians 
News Trial Stats
Clinical TrialsFacts & Fears Who pays for it, placebos, being a guinea pig, and what taking part really means.Basics ofTheranostics A fundamental way of finding and treating your cancer, all in one.Basics ofRadiation What is radiation, and how can it benefit you? InterpretingYour Scans What CT, MRI and PET can and can’t tell you about cancer.What to Expect as aTheranostic Patient Scans, treatment day, and the precautions once you are home.Basics ofDosimetry How much radiation each organ and tumor actually absorbs.TheranosticDictionary Plain-language meanings for the vocabulary on your paperwork.
News Trial StatsDark mode
Contact XCancer®
Mon–Thu 8am–4:30pm CT · Fri 8am–3pm CT
Clinical Trial · NCT00088881
Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma
Overview
This phase II trial is studying how well giving rituximab together with combination chemotherapy and 90-Yttrium ibritumomab tiuxetan works in treating patients with stage I or stage II lymphoma. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab and yttrium 90-Yttrium ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining a monoclonal antibody with combination chemotherapy and a radiolabeled monoclonal antibody may kill more cancer cells.
Sponsor
National Cancer Institute
Phase
Phase 2
Contacts
Thomas Witzig (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT00088881Drug / Compound
ibritumomab tiuxetan
Isotope(s):
INDIUM-111
Radioisotope: In-111
Theranostic Role: SPECT Imaging
T1/2 (Half-Life): 2.8 Days
Decay Mode: ELECTRON CAPTURE, GAMMA
Energy: 173 keV, 247 keV
Range: N/A
Decay Daughters: Cd111 (Stable)
Status: FDA Approvals: ONCOSCINT® (1992), OCTREOSCAN® (1994)
Target(s):
- cd20
Ligand Class: Antibodies
Chelator: tiuxetan
ibritumomab tiuxetan
Isotope(s):
YTTRIUM-90
Radioisotope: Y-90
Theranostic Role: Therapeutic Agent, SPECT Imaging & PET Imaging
T1/2 (Half-Life): 2.7 Days
Decay Mode: BETA
Energy: max 2.2 MeV
Range: In Tissue: Avg 2.5 mm, Max 11 mm; In Air: 35 feet
Decay Daughters: Zr90 (Stable)
Status: FDA Approvals: SIR-SPHERES® (2000), THERASPHERES® (2021)
Target(s):
- cd20
Ligand Class: Antibodies
Chelator: tiuxetan
Eligibility
Inclusion
- Patients must be tested for hepatitis B (HBV) surface antigen within 2 weeks of registration
- Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease unless verified by CT scan or other appropriate imaging; patients must have at least one objective measurable disease parameter (a lesion with at least 1 dimension \> 1.5 cm); or if they are stage 1
- Patients must have histologically confirmed diagnosis of diffuse large cell lymphoma
- Creatinine \< 2.0 mg/dl
- Total bilirubin \< 2 mg/dl (may be up to 3.0 mg/dl if due to liver involvement by lymphoma); patients with elevated total bilirubin should have a direct bilirubin checked; if the direct bilirubin is normal there is no need for a dose reduction
- Eastern Cooperative Oncology Group (ECOG) performance status = 2
- NOTE: Patients who test positive will be allowed to participate but must be followed closely for clinical and laboratory signs of active HBV infection and for signs of hepatitis
- Elevated Lactate Dehydrogenase (LDH) above institutional upper limit of normal
- Absolute neutrophil count \>= 1500/mm\^3 (includes neutrophils and bands)
- Patients must have left ventricular ejection fraction (LVEF) of \> 45%
- Bulky disease (\>= 5 cm in at least one dimension)
- Platelet count \>= 100,000/mm\^3
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must be stage I or II (Modified Ann Arbor staging)
- Stage I patients must have at least one of the following risk factors:
Exclusion
- Adjuvant hormonal therapy must have been discontinued \> 3 months before entering this study
- Evidence of myelodysplasia on bone marrow aspiration and biopsy
- Serious coexisting medical condition or active infection which would compromise the ability to deliver standard R-CHOP chemotherapy
- Pregnant or breast feeding, as there would be radiation exposure to the fetus or child; a negative pregnancy test is required =\< 1 week prior to registration for women of childbearing potential (WOCBP). Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
- Prior chemotherapy or prior radiation therapy for other malignancies
- Prior chemotherapy, radiation therapy, radioimmunotherapy, or immunotherapy; a short course (=\< 14 days prior to registration) of corticosteroids is allowed
- Known HIV infection. The safety of Zevalin™ in this population has not been tested at this time
- Evidence of other malignancy:
- Known central nervous system (CNS) lymphoma, testicular lymphoma, or vitreous lymphoma
- Currently receiving hormone therapy or chemotherapy for another malignancy even if the treatment is being provided in the adjuvant treatment setting, i.e. with no evidence of the original other malignancy
Share your feedback
Help us improve your experience