Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

B-cell Lymphoma

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Carboplatin

Etoposide

Rituximab

Ifosfamide

Etoposide phosphate

Isophosphamide mustard

Antineoplastic Agents, Immunological

Immunologic Factors

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

90Y Zevalin

John D. Hainsworth, MD

In this Multicenter trial, we will evaluate the feasibility, toxicity, and efficacy of treatment with 90Y Zevalin following a short course of salvage chemotherapy in patients with relapsed/refractory intermediate grade B-cell non-Hodgkin's lymphoma.

Upon determination of eligibility, patients will receive:

* Ifosfamide + Carboplatin + Etoposide + Rituximab

Patients showing no response to this combination regimen will receive 90Y Zevalin after two cycles or when progression is clearly documented. In responding patients, four cycles will be administered, followed by 90Y Zevalin.

Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma

Phase II Trial of Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in the Treatment of Patients With Relapsed/Refractory Intermediate Grade B-Cell Lymphoma

Biogen

SCRI Development Innovations, LLC

John Hainsworth, MD

Symptoms and General Pathology

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Hematologic Diseases

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Antimetabolites

Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.

Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg

Zevalin Radioimmunotherapy

750 mg/m\^2/day for 3 days, given on the same days as fludarabine, at 4-hour intervals

Allogeneic stem cell transplantation 2 days after chemotherapy

Allogeneic Stem Cell Transplantation

Issa F. Khouri, MD

The goal of this clinical research study is to see if low intensity chemotherapy given together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem cells from a donor can increase the length of remission in patients with leukemia and lymphoma. The safety of this treatment will also be studied.

Rituxan is an antibody made from human and mouse protein. It reacts with a certain antigen on lymphoma cells and causes the body's immune system to destroy the lymphoma cells. 90Y Zevalin and 111In Zevalin are murine-based antibodies combined with a radioactive agent that can also destroy lymphoma cells. Unlike Rituxan, 90Y Zevalin cannot be traced by regular scanning and requires indium to determine its distribution through the body.

Before treatment starts, patients will have a physical exam, including blood tests and urine tests. Women who are able to have children must have a negative blood pregnancy test. Bone marrow samples will be taken. For bone marrow sampling, a large needle is placed in the hipbone after it has been numbed. The bone marrow is then withdrawn through the needle. Patients will have a chest x-ray, computed tomography (CT) scans, an EKG, and tests of lung function.

Blood tests, urine tests, bone marrow sampling, and x-rays will be done as needed to track the effects of the transplant. Patients will have transfusions of blood and platelets as needed. Blood tests will be done daily while patients are in the hospital.

Patients in this study will receive an unlabeled antibody form of Y2B8 called rituxan by vein followed by a dose of 111In Zevalin by vein. 111In Zevalin includes the radioactive agent indium, which shows up when patients have x-rays or scans. The scans can show where and how fast the drug travels in the body and how long the drug stays in the body. Doctors need to be able to see how much of the drug goes to the tumor and how much goes to normal organs to see if it is safe to give 90Y Zevalin on an outpatient basis. A scan will be taken 48 to 72 hours after 111In Zevalin is given.

If the radiation in the 111In Zevalin is not a threat to normal organs and bone marrow, patients may receive 90Y Zevalin. Seven days after the 111In Zevalin injection, patients will receive a second dose of rituxan followed by a dose of 90Y Zevalin.

Patients will also receive fludarabine and cyclophosphamide daily for 3 days. All of the chemotherapy drugs will be given through a catheter (plastic tube) that extends into the large chest vein. The catheter will be left in place throughout treatment. When chemotherapy is finished, blood stem cells from a donor will be given through the catheter. Granulocyte colony-stimulating factor (G-CSF or GCSF), a hormone that helps the production of blood cells, will be injected under the skin once a day until the neutrophil counts recover in the blood. Patients will receive methotrexate for 3 days post transplant and tacrolimus for 6 months or more to prevent graft versus host disease.

All patients will have complete checkups, including blood and urine tests 2 or 3 times during the first 12 weeks of the study. Tumors will be measured by CT or MRI and gallium scans. Patients will be asked to fill out a survey about quality of life issues (maintaining normal routine, family life, social life, pain). It takes about half an hour to fill out the survey. A bone marrow sample may be taken. A test of heart function will be done. Checkups and tests will be done every 3 months for 1 year and then every 6 months for 4 more years.

Treatment will be given in the hospital at M. D. Anderson. Patients will need to stay in the hospital for about 3 to 4 weeks. Patients must stay in the Houston area for about 100 days after the transplant. After that, patients will need to return to Houston from time to time for blood tests, urine tests, and other exams.

This is an investigational study. 90Y-Zevalin is approved by the FDA for relapsed and refractory lymphoma. Its use in this trial, however, is investigational. About 70 patients will take part in this study. All will be enrolled at M. D. Anderson.

Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies

Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells.

M.D. Anderson Cancer Center

Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.

Rituximab : 250 mg/m\^2 on day 1 and day 8

Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy

Cyclophosphamide : 750 mg/m\^2/day x 3, given on the same days as fludarabine, at 4-hour intervals

Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg

Fludarabine : 30 mg/m\^2/day x 3

90Y Zevalin in ASCT

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Issa Khouri, MD / Professor

Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.

Rituximab: 250 mg/m\^2 on day 1 and day 8

Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy

Cyclophosphamide : 750 mg/m\^2/day x 3, given on the same days as fludarabine, at 4-hour intervals

Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg

Fludarabine : 30 mg/m\^2/day x 3

Number of Participants With Graft Failure

Overall Study

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Antibodies

Tin Fluorides

Immunoconjugates

Immunoglobulins

Antibodies, Monoclonal

1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.

1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging. 111In Zevalin will be administered by a 10 minute slow IV push injection immediately following completion of the rituximab infusion. 111In Zevalin may be injected by stopping the flow from the IV bag and injecting the radiolabeled antibody directly into the IV line. A 0.22 micron filter must be on line between the drug infusion port and the patient. The line must be flushed with at least 10cc of normal saline after 111In Zevalin has been injected.

indium-111-ibritumomab tiuxetan

Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi. 90Y Zevalin will be administered intravenously as a slow IV push over 10 minutes. 90Y Zevalin may be directly infused by stopping the flow from the IV bag and injecting the radiolabeled antibody directly into the IV line. A 0.22 micron filter must be on line between the syringe and the infusion port. The line must be flushed with at least 10cc normal saline after 90Y Zevalin has been infused.

Andreas K Klein, MD

The study involves the use of a targeted form of radiation, in addition to standard high dose chemotherapy and stem cell transplant for multiple myeloma. The use of targeted radiation is designed to kill more multiple myeloma cells while avoiding the side effects of standard radiation. This type of targeted radiation (also known as radioimmunotherapy) has been approved by the Food and Drug Administration (FDA) for the treatment of a related disease, lymphoma under the trade name, Zevalin©. Zevalin© has been added to high dose chemotherapy and stem cell transplants for patients with lymphoma and is now being studied in this clinical trial for patients with multiple myeloma. This trial is only available at Tufts Medical Center.

The proposed clinical trial will test whether CD20-targeted radio-immunotherapy can be safe and effective when integrated into a standard regimen of myeloablative chemotherapy and autologous stem cell rescue in patients with measurable disease prior to high dose chemotherapy and autologous stem cell transplant for multiple myeloma.

Patients with multiple myeloma scheduled for standard of care high dose melphalan and autologous stem cell transplant who have an incomplete response to induction treatment (i.e. with measurable disease) following peripheral blood stem cell collection are candidates for participation on this trial. 90Y Zevalin targets CD20 expressed on the surface of mature B-cells and is FDA approved for relapsed/refractory low grade lymphoma. This is a single arm, phase II safety and efficacy study of 90-Y Zevalin in multiple myeloma. Subjects will receive cold antibody (Rituximab 100mg/m2) followed by 5 mCi test dose of 111-In Zevalin on transplant day -21. Gamma camera images are obtained 48 to 72 hours after 111-In Zevalin to document appropriate / expected distribution of radiotracer. On transplant day -14, subjects will receive another cold antibody dose followed by 90Y Zevalin 0.4 mg/kg (max 32 mCi) as single dose. Subjects are admitted for transplant on day -3 and proceed with institution standard high dose melphalan (200mg/m2) on day -2. Subjects are followed for safety for 6 weeks after transplant.

Zevalin for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma

A Phase II, Safety and Efficacy Study of Fixed Dose Radioimmunotherapy (Zevalin, Yttrium-90 Ibritumomab Tiuxetan) for Patients With Incomplete Response to Chemotherapy Prior to Autologous Stem Cell Transplant for Multiple Myeloma

Efficacy: objective response rate (CR + PR) at 12 and 104 days following radioimmunotherapy. Safety: the rate of occurrence of defined toxic events including non-engraftment and unacceptable biodistribution of 90Y Zevalin occurring by day +42 following transplant. Response determined according to Blade' Criteria (Bladé J, Br J Haematol.1998 Sep;102(5):1115-23) for multiple myeloma; Response based on reduction of monoclonal protein (M-protein) from initial presentation.

Number of days from stem cell infusion (day +0) to day of neutrophil engraftment (first of three consecutive days with absolute neutrophil count \> 500)

CD20 immunohistochemical staining of plasma cells on baseline bone marrow biopsy specimen, graded on qualitative scale (0 to +++)

Spectrum Pharmaceuticals, Inc

Tufts Medical Center

Zevalin

Race (NIH/OMB)

Simon two-stage, min-max design test the hypothesis H0: p\</=0.05 (the expected response rate for no treatment) versus Ha: p\>/=0.30 (a clinically significant response rate) with a=0.05 and b=0.20.

Andreas Klein, MD

CR/PR at +12 days

CR/PR at +104 days

Participants with toxic events

90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.

6 subjects had objectively measurable disease and were evaluable for response, 8 subjects received study intervention and are evaluable for safety

Safety and Efficacy

Time to Engraftment in Patients Who Proceed to Myeloablative Chemotherapy After Receiving 90Y Zevalin® (Ibritumomab Tiuxetan).

Immunohistochemical analysis showed inconsistent / insufficient CD20 staining on surface of plasma cells; comparisons could not be made

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma	NCT00193505	Non-Hodgkins Ly...	Ifosfamide Carboplatin Etoposide Rituximab 90Y Zevalin	18 Years -	SCRI Development Innovations, LLC
Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies	NCT00048737	Lymphoma Leukemia	Zevalin Radioim... Rituximab Fludarabine Cyclophosphamid... Allogeneic Stem...	18 Years - 70 Years	M.D. Anderson Cancer Center
Zevalin for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma	NCT01207765	Multiple Myelom...	indium-111-ibri... 90Y Zevalin	18 Years - 70 Years	Tufts Medical Center

Spots Global Cancer Trial Database for 90y zevalin

Every month we try and update this database with for 90y zevalin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 90y zevalin

Every month we try and update this database with for 90y zevalin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 90y zevalin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.