Study Of Yttrium-Ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Biogen Idec
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038623

Purpose

Study of Yttrium-ibritumomab (Zevalin) For the treatment of Patients with Relapsed & Refractory Mantle Cell Lymphoma

Condition	Intervention	Phase
Lymphoma, Mantle-Cell	Drug: Yttrium-ibritumomab (Zevalin) Drug: Rituximab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study Of Yttrium-Ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Rituximab Ibritumomab tiuxetan

U.S. FDA Resources

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

Primary Outcome Measures:

To learn if Ibritumomab tiuxetan (ZEVALIN, 90 Yttrium Zevalin) can shrink or slow the growth of tumors in patients with relapsed or refractory mantle cell lymphoma. [ Time Frame: 7 Years ] [ Designated as safety issue: Yes ]

Enrollment:	35
Study Start Date:	April 2002
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Yttrium-ibritumomab (Zevalin)	Drug: Yttrium-ibritumomab (Zevalin) After Rituximab infusion, 111^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then then Day 2. Drug: Rituximab 250 mg/m^2 in the vein over 6 to 8 hours on Day 1.

Detailed Description:

Mantle cell lymphoma cell express a protein called CD20. Ibritumomab tiuxetan is an antibody targeted against CD20, which carries a radioactive material called 90-Yttrium. The radioactivity will be delivered to the cancer cells by the antibody will help killing the mantle cell lymphoma cells. Before treatment starts, patients will have a physical exam, including blood and urine test. Patients will have a chest x-ray and CT scans of the abdomen and pelvis. Bone marrow samples will be taken with a large needle. A cardiogram (EKG) will be performed before therapy and after 1 and 3 months of therapy.

Patients in this study will receive one dose of rituximab in the vein over 6 to 8 hours on the first day of treatment. This will be followed by an infusion of antibody labeled with radioactive indium, which will allow imaging of the tumor sites and normal tissue site that will bind the antibody.

Imaging will be performed twice in the nuclear medicine department of Day 1, and once on either Day 2 or 3. On day 8 (7 days after the first dose of rituximab), patients will receive a second dose of rituximab. This will immediately be followed by a dose of Ibritumomab tiuxetan given by vein over ten minutes. Patients will receive diphenhydramine (Benadryl) by vein and mouth and acetaminophen (Tylenol) by mouth before each dose of rituximab. This is done to prevent fever and chills. All treatments will be given in an outpatient setting.

Blood test will be taken weekly during the first 3 months, the every 3 months for 1 year, and then every 6 months for 3 years. CT scans, x-rays, and bone marrow biopsies will be repeated if needed after 3 months of therapy and every 3 months for 1 years, then every 6 months for 3 years. If tumors do not shrink after 3 months of therapy or increase in size, patients will be offered a different treatment.

This is an investigational study. Up to 35 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Histologically confirmed, relapsed or refractory mantle cell lymphoma requiring treatment.
No anti-cancer therapy for three weeks (6 weeks if rituximab, nitrosurea, or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy.
An IRB-approved signed informed consent.
Age greater or equal to 18 years.
Expected survival greater than or equal to 3 months.
Pre-study performance status of 0, 1, or 2 according to the WHO criteria.
Acceptable hematologic status within two weeks prior to patient registration, including: Absolute neutrophil count (segmented neutrophils = bands x total WBC)greater than or equal to 1,500/mm^3; Platelets greater than or equal to 1000,000/mm^3.
Female patients who are not pregnant or lactating.
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).
Patients previously on investigational Phase II anti-cancer drugs if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post treatment toxicities observed.
Patients determined to have less than 25% bone marrow involvement with mantle cell lymphoma within six weeks of registration. Measurement to be determined by bilateral bone marrow biopsies. This criteria must be strictly met for adequate patient safety.

Exclusion Criteria:

Prior autologous or allogeneic bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue therapy.
Prior radioimmunotherapy.
Presence of CNS lymphoma.
Patients with HIV or AIDS-related lymphoma.
Patients with pleural effusion.
Patients with abnormal liver function: Total bilirubin greater than 2.0mg/dL
Patients with abnormal renal function: serum creatinine greater than 2.0mg/dL
Patients who have received prior external beam radiotherapy to greater than 25% of active bone (involved field or regional).
Patients who have received G-CSF or GM-CSF therapy within two weeks prior to treatment.
Serious nonmalignant disease or infection which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives.
Major surgery, other than diagnostic surgery, within four weeks.
Impaired bone marrow reserve as indicated by one or more of the following: a) History of failed stem cell collection. b) Platelet count less than 1000,000 cells/mm^3. c) Hypocellular bone marrow (less than 15% cellularity). d) Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid).
Presence of leukemic phase of disease defined as peripheral blood absolute lymphocyte count of greater than 5,000/microliters.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038623

Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Biogen Idec

Investigators

Principal Investigator:

Anas Younes, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Anas Younes, MD/Professor )
Study ID Numbers:	ID01-541
Study First Received:	June 3, 2002
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00038623 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Relapsed/Refractory Mantle Cell Lymphoma
Yttrium-Ibritumomab
Zevalin

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Lymphoma, Mantle-Cell
Physiological Effects of Drugs

Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on November 25, 2009