NCT00022880

Brief Summary

The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody, to see what effects it has on patients with CLL and to determine the highest dose of Iodine-131 Anti-B1 Antibody that can be given without causing severe side effects.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2001

Completed
Last Updated

June 24, 2005

Status Verified

August 1, 2004

First QC Date

August 15, 2001

Last Update Submit

June 23, 2005

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic LeukemiaDose-EscalationRadioimmunotherapyMonoclonal AntibodyCorixaBexxarAnti-B1 AntibodyTositumomabIodine -131 Anti-B1 AntibodyIodine I 131 Tositumomab

Interventions

Iodine-131 Anti-B1 AntibodyDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must fulfill the criteria for the diagnosis of intermediate-risk B-cell CLL or high-risk B-cell CLL
  • The bone marrow aspirate must demonstrate that greater than or equal to 30% of all nucleated cells are lymphoid.
  • Patients must have evidence that their leukemic lymphocytes express the CD20 antigen.
  • Patients must have been previously treated with chemotherapy or biologic therapy and have progressed on, failed to achieve an objective response (CR or partial response \[PR\]) on, or progressed after completion of last therapy. Patients must have received at least one therapy containing a purine nucleoside analogue. Patients must not have received more than 4 prior therapies. This includes both chemotherapy and biologic therapy.
  • Patients must have an absolute granulocyte count \>500 cells/mm3 and a platelet count of either \>100,000 cells/mm3 (Cohort A) or a platelet count of 75,000-100,000 cells/mm3 deemed to be secondary to CLL by the investigator, (Cohort B) within 14 days of study entry. These blood counts must be sustained for 4 weeks without support of hematopoietic cytokines or transfusion of blood products.
  • Patients must have a Karnofsky Performance status of at least 60% and an anticipated survival of at least 3 months.
  • Patients must have adequate renal function (defined as serum creatinine \<1.5 x upper limit of normal \[ULN\]) and hepatic function (defined as total bilirubin \<1.5 x ULN and AST \<3 x ULN) within 14 days of study entry. For patients with autoimmune hemolytic anemia, the bilirubin must be less than or equal to 8 x ULN.

You may not qualify if:

  • Patients who have received prior therapy with cytotoxic chemotherapy or immunosuppressants (with the exception of maintenance prednisone therapy not to exceed a dose of 20 mg/day for autoimmune hemolysis only) within FOUR weeks prior to study entry (6 weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. The prednisone must have been started more than 4 weeks prior to study entry.
  • Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with \>3500 cGy.
  • Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.
  • Patients with active obstructive hydronephrosis.
  • Patients with prior malignancy other than CLL, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. Patients who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study entry to rule out recurrent disease.
  • Patients with known HIV infection.
  • Patients who are pregnant or nursing. Patients of childbearing potential must undergo a serum pregnancy test within 7 days prior to study entry. Males and females must agree to use a contraceptive method from enrollment to 6 months after receiving Iodine-131 Anti-B1 Antibody.
  • Patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
  • Patients with evidence of active infection requiring intravenous treatment with anti-infectives.
  • Patients known to be HAMA positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11041, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

tositumomab I-131

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 15, 2001

First Posted

August 17, 2001

Study Start

July 1, 1999

Last Updated

June 24, 2005

Record last verified: 2004-08

Locations

US(2)