Zevalin (Ibritumomab Tiuxetan) for Early Stage Indolent Lymphomas

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00493467
First received: June 27, 2007
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

The goal of this clinical research study is to find out if giving (Rituxan) rituximab with 90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma. The safety of this combination treatment will also be studied.


Condition Intervention Phase
Lymphoma
Drug: Ibritumomab Tiuxetan (Zevalin)
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Zevalin for the Treatment of Early-Stage Indolent Lymphomas

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Evaulation one month following completion of treatment and performed by CT scan or MRI. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: June 2006
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zevalin
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Drug: Ibritumomab Tiuxetan (Zevalin)

111In Zevalin (5 mCi of ^111In, 1.6 mg of Ibritumomab Tiuxetan) Intravenously Over 10 minutes on Day 1.

90Y Zevalin 0.3 or 0.4 mCi/kg Intravenously Over 10 minutes on Day 8.

Other Names:
  • Ibritumomab
  • Zevalin
  • IDEC-Y2B8
Drug: Rituximab
250 mg/m^2 Intravenously Over 4-6 Hours On Days 1 and 8.
Other Name: Rituxan

Detailed Description:

90 Y Zevalin and rituximab are both designed to attach to lymphoma cells, causing them to die.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam. Blood (about 2 to 3 teaspoons) and urine will be collected for routine tests. You will have a chest x-ray and computerized tomography (CT) scans of the neck, chest, abdomen (stomach area), and pelvis.

A PET scan is also recommended. A PET (Positron Emission Tomography) scan is a medical technique that monitors the activity in the brain and other organs by tracking the movement of a special radioactive solution through the body. The radioactive solution is either inhaled as a mist or injected into a vein. The radioactive solution is usually made from simple sugar that has radioactive particles attached to it. After the solution is injected into a vein or inhaled, the PET scanner takes pictures of the radioactive solution as it moves through the body and collects in various organs. By watching how the solution travels through the body and studying where the solution collects, researchers can learn the extent of disease in certain organs in the body.

You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will have a bone marrow aspirate and biopsy performed. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.

If you are found to be eligible to take part in this study, you will be given diphenhydramine (Benadryl) by vein and you will take acetaminophen (Tylenol) by mouth before each dose of rituximab. This is done to help decrease the risk of developing side effects of rituximab. You will then receive 1 dose of rituximab by vein over about 4-6 hours on Day 1 of treatment. After treatment with rituximab, you will then be given 111 In Zevalin (this is a radioactive agent that binds to rituximab to help with imaging exams), by vein over about 10 minutes. This is so researchers can use a special camera to see where the drug is in your body.

You will have imaging performed (on a camera, like an x-ray) on either Day 2 or 3. On Day 8 (7 days after the first dose of rituximab) you will receive a second dose of rituximab. You will also be given Benadryl, Tylenol, and 90Y Zevalin in the same manner as on Day 1.

If you experience intolerable side effects while on this study, you may be removed from this study. Your treatment on the study will end on Day 8.

You will return for follow-up tests for 4 years. Blood (about 2 tablespoons) will be drawn weekly for the first 3 months. Blood (about 2 tablespoons each time) will also be drawn at month 6 and 9 of the first year, and every 6 months in the second, third, and fourth years. You may also have CT scans, PET scans (which are recommended), x-rays, and bone marrow biopsies and aspirates performed, if your doctor thinks they are necessary.

Your participation on this study will end in about 4 years.

This is an investigational study. 90 Y Zevalin and rituximab are FDA approved and commercially available. Their use in this study is investigational. Up to 36 patients will take part in this multicenter study. Up to 36 patients will be enrolled at M. D. Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. New diagnosis of low-grade indolent lymphomas Stage I-II. Patients with multiple skin lesions will be eligible provided that the skin is the only site of involvement.
  2. Histology includes Indolent CD20+ lymphomas including: Follicular lymphoma, Extranodal marginal lymphoma of MALT type, Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells), and Splenic marginal B-cell lymphoma (+/- villous lymphocytes).
  3. Signed Informed Consent.
  4. Age >/= 18 years.
  5. Pre-study Zubrod performance status of 0, 1, or 2.
  6. Acceptable hematologic status within two weeks prior to patient registration, including: absolute neutrophil count ([segmented neutrophils + bands] x total WBC) >/= 1, 500/mm^3, total lymphocyte count </= 5,000/mm^3 and platelet counts >/= 100,000/mm^3.
  7. Female patients who are not pregnant or lactating.
  8. Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method).
  9. Patients determined to have < 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy).
  10. Patient should have at least one lesion measuring >/= 1.5 cm in a single dimension. Measurable cutaneous lesions are allowed.

Exclusion Criteria:

  1. Presence of CNS lymphoma.
  2. Patients with HIV or AIDS-related lymphoma.
  3. Patients with pleural effusion.
  4. Patients with abnormal liver function: total bilirubin > 2.0 mg/dL.
  5. Patients with abnormal renal function: serum creatinine > 2.0 mg/dL.
  6. Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional).
  7. Impaired bone marrow reserve as indicated by < 15% bone marrow cellularity
  8. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
  9. Major surgery, other than diagnostic surgery, within four weeks.
  10. Evidence of transformation in the latest biopsy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493467

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Biogen Idec
Investigators
Principal Investigator: Felipe Samaniego, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00493467     History of Changes
Other Study ID Numbers: 2005-0512
Study First Received: June 27, 2007
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Non-Hodgkin's Lymphoma
Lymphoma
Indolent Lymphomas
Ibritumomab Tiuxetan
Zevalin

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 15, 2014