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Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas

Primary Purpose

Lymphoma

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Zevalin

Rituximab

^111 In Ibritumomab Tiuxetan

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Indolent Lymphoma, Extranodal Marginal, Nodal Marginal Zone, Splenic Marginal, MALT Type, Zevalin, Ibritumomab Tiuxetan, Rituximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from acute toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy.
Previously treated patients with a histology of refractory/relapsed indolent lymphomas including: (a) Extranodal marginal lymphoma of MALT type; (b) Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells); (c) Splenic marginal B-cell lymphoma (+/- villous lymphocytes).
Signed informed consent
Age >/= 18 years
Expected survival >/= 3 months
Pre-study Zubrod performance status of 0, 1, or 2
Acceptable hematologic status within two weeks prior to patient registration, including: (a) Absolute neutrophil count ([segmented neutrophils + bands] * total white blood count (WBC)) >/= 1,500/mm^3; (b) Platelet counts >/= 100,000/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)
Patients previously on Phase II 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 < 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy) (This criteria must be strictly met for adequate patient safety.)
Patient should have at least one lesion measuring >/= 2 cm in a single dimension.

Exclusion Criteria:

Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue.
Platelet count< 100,000 cells/mm^3.
Presence of hypocellular bone marrow.
Patients with history of failed stem cell collection.
Prior radioimmunotherapy
Presence of Central Nervous System (CNS) lymphoma
Patients with HIV.
Patients with pleural effusion
Patients with abnormal liver function: total bilirubin > 2.0 mg/dL
Patients with abnormal renal function: serum creatinine > 2.0 mg/dL
Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional)
Patients who have received short-acting growth factor support (Leukine, Neupogen, Procrit) within 2 weeks prior to treatment or long-acting growth-factor support (Aranesp), Neulasta) within 4 weeks prior to treatment.
Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives
Major surgery, other than diagnostic surgery, within four weeks
Evidence of transformation in the latest biopsy

Sites / Locations

UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ibritumomab tiuxetan + Rituximab

Arm Description

Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.

Outcomes

Primary Outcome Measures

Objective Response Rate

Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.

Secondary Outcome Measures

Full Information

NCT ID

NCT00493454

First Posted

June 27, 2007

Last Updated

May 30, 2013

Sponsor

M.D. Anderson Cancer Center

Collaborators

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT00493454

Brief Title

Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas

Official Title

Multicenter Phase II Study for Zevalin® in Patients With Relapsed/Refractory Indolent Lymphomas: Extranodal Marginal Lymphoma of MALT Type, Nodal Marginal Zone B-Cell Lymphoma, and Splenic Marginal B-Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual.

Study Start Date

April 2006 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: Overall Response Rate (ORR). Secondary Objectives: The Duration of Response (DR) and Time to Treatment Progression (TTP) in all patients and in the responders. Complete Responses (CR)/Complete Responses unconfirmed (CRu), and Partial Responses (PR). Time to next anticancer therapy (TTNT).

Detailed Description

^90 Y Ibritumomab tiuxetan 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 what are called "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. Your 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, and pelvis. 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 pregnancy test. The study doctors will first make sure that your disease has not spread too much and is not too severe to require immediate treatment with chemotherapy before you can begin treatment on this study. If you are found to be eligible to take part in this study, you will be given Benadryl (diphenhydramine) by vein, and you will be given Tylenol (acetaminophen) 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 6 to 8 hours on Day 1 of treatment. After treatment with rituximab, you will then be given a radioactive antibody, ^111 In Ibritumomab tiuxetan (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 (with the special camera) on Day 1 and on either Day 2 or Day 3. On Day 8, you will receive a second dose of rituximab. This will then be followed by a dose ^90 Y Ibritumomab tiuxetan of given by vein over 10 minutes. This completes the treatment. If you experience intolerable side effects while on this study, you may be removed from this study. The study doctor will then offer other treatment options to you. For your follow-up, you will have blood (about 2 tablespoons) drawn once a week for the first 3 months, then every 3 months for 1 year, and then every 4 months for the second year. At these visits, you may also have CT scans, x-rays, and bone marrow biopsies and aspirates performed, if needed. This is an investigational study. ^90 Y Ibritumomab tiuxetan and rituximab have been approved by the FDA for the treatment of indolent B-cell lymphoma. Up to 35 patients will take part in this multicenter study. Up to 15 will be enrolled at M. D. Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

Indolent Lymphoma, Extranodal Marginal, Nodal Marginal Zone, Splenic Marginal, MALT Type, Zevalin, Ibritumomab Tiuxetan, Rituximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ibritumomab tiuxetan + Rituximab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Zevalin

Other Intervention Name(s)

Ibritumomab Tiuxetan

Intervention Description

.3 mCi IV Over 10 Minutes x 1 Day

Intervention Type

Drug

Intervention Name(s)

Rituximab

Intervention Description

250 mg/m^2 IV Over 6 to 8 Hours

Intervention Type

Drug

Intervention Name(s)

^111 In Ibritumomab Tiuxetan

Other Intervention Name(s)

Indium-111

Intervention Description

1.6 mg IV Over 10 Minutes x 1 Day

Primary Outcome Measure Information:

Title

Objective Response Rate

Description

Time Frame

Evaluation 4 weeks after administration of Zevalin up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from acute toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy. Previously treated patients with a histology of refractory/relapsed indolent lymphomas including: (a) Extranodal marginal lymphoma of MALT type; (b) Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells); (c) Splenic marginal B-cell lymphoma (+/- villous lymphocytes). Signed informed consent Age >/= 18 years Expected survival >/= 3 months Pre-study Zubrod performance status of 0, 1, or 2 Acceptable hematologic status within two weeks prior to patient registration, including: (a) Absolute neutrophil count ([segmented neutrophils + bands] * total white blood count (WBC)) >/= 1,500/mm^3; (b) Platelet counts >/= 100,000/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) Patients previously on Phase II 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 < 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy) (This criteria must be strictly met for adequate patient safety.) Patient should have at least one lesion measuring >/= 2 cm in a single dimension. Exclusion Criteria: Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue. Platelet count< 100,000 cells/mm^3. Presence of hypocellular bone marrow. Patients with history of failed stem cell collection. Prior radioimmunotherapy Presence of Central Nervous System (CNS) lymphoma Patients with HIV. Patients with pleural effusion Patients with abnormal liver function: total bilirubin > 2.0 mg/dL Patients with abnormal renal function: serum creatinine > 2.0 mg/dL Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional) Patients who have received short-acting growth factor support (Leukine, Neupogen, Procrit) within 2 weeks prior to treatment or long-acting growth-factor support (Aranesp), Neulasta) within 4 weeks prior to treatment. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives Major surgery, other than diagnostic surgery, within four weeks Evidence of transformation in the latest biopsy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felipe Samaniego, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

The University of Texas M.D.Anderson Cancer Center Official Web Site

Learn more about this trial

Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas

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