Expired Study
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Omaha, Nebraska 68198


Purpose:

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase III trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.


Study summary:

OBJECTIVES: I. Determine the efficacy and safety of iodine I 131 monoclonal antibody anti-B1 in patients with relapsed or refractory, low grade or transformed low grade B-cell non-Hodgkin's lymphoma. OUTLINE: On day 1, patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV over 1 hour followed by a tracer dose of iodine I 131 MOAB anti-B1 IV over 30 minutes to determine biodistribution and a therapeutic dose of iodine I 131 MOAB anti-B1. Patients receive unlabeled MOAB anti-B1 IV over 1 hour followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 30 minutes on day 8. Patients are followed at weeks 13 and 25 and then every 6 months for up to 2 years. PROJECTED ACCRUAL: Expanded Access Trial, no maximum accrual


Criteria:

DISEASE CHARACTERISTICS: Histologically proven relapsed or refractory, low grade or transformed low grade B-cell non-Hodgkin's lymphoma including the following: Small lymphocytic Follicular small cleaved cell Follicular mixed small cleaved and large cell (less than 50% large cell component) Tumor must be positive for CD20 antigen Relapse or disease progression following at least 1 chemotherapy regimen or failure to achieve an objective response (complete or partial response) on prior chemotherapy regimen No disease progression, within 1 year of irradiation, arising in a field previously irradiated with more than 3500 cGy Mean of no greater than 25% intratrabecular marrow space involved with lymphoma on bilateral iliac crest bone marrow biopsy A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 19 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST less than 5 times ULN Renal: Creatinine less than 1.5 times ULN No active obstructive hydronephrosis Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active infection requiring IV antibiotics No other concurrent illness that would preclude evaluation No prior malignancy within the past 5 years except adequately treated skin cancer, carcinoma in situ of the cervix, or lymphoma HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No prior allergic reaction to iodine other than IV iodine containing contrast materials Human antimouse antibody negative PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy or cytokine treatment and recovered No prior hematologic stem cell transplantation Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior radioimmunotherapy Surgery: Not specified Other: No concurrent IV antibiotics


Study is Available At:


Original ID:

259-98


NCT ID:

NCT00004874


Secondary ID:

P30CA036727


Study Acronym:


Brief Title:

Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma


Official Title:

Expanded Access Study of Iodine-131 Anti-B1 Antibody for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

19 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Nebraska


Oversight Authority:

  • United States: Federal Government
  • United States: Food and Drug Administration


Reasons Why Stopped:

lack of FDA approval


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

31


Enrollment Type:

Actual


Overall Contact Information

Official Name:Julie M. Vose, MD
Study Chair
University of Nebraska

Study Dates

Start Date:November 1998
Completion Date:November 2012
Completion Type:Actual
Primary Completion Date:April 2002
Primary Completion Type:Actual
Verification Date:January 2018
Last Changed Date:January 13, 2018
First Received Date:March 7, 2000

Study Outcomes

Outcome Type:Secondary Outcome
Measure:efficacy
Time Frame:study completion
Safety Issues:False
Description:Secondary endpoints of the study will be to obtain additional information on the efficacy of Iodine-131 Anti-B1 Antibody
Outcome Type:Secondary Outcome
Measure:Safety
Time Frame:Study completion
Safety Issues:False
Description:Secondary endpoints of the study will be to obtain additional information on the safety of Iodine-131 Anti-B1 Antibody
Outcome Type:Primary Outcome
Measure:Expanded Access
Time Frame:Study completion
Safety Issues:False
Description:The primary objective of this stud is to make Iodin-131 Anti-B1 Antibody more broadly available to patients

Study Interventions

Intervention Type:Radiation
Name:tositumomab and iodine I 131 tositumomab
Description:Dosimetric Dose:Unlabeled anti-B1 (450mg) will be given as peripheral or central IV infusion over one hour or longer depending upon rate-dependent side effects. A trace-labeled dose of 131I-anti-B will be infused over 20 minutes, if rate-dependent side effects permit. An amount of unlabeled Anti-B1 Antibody is added to the 5 mCi of Iodine-131 Anti-B1 Antibody sufficient to result in a final amount of 35 mg of Anti-B1 antibody. On study Day 7 (may be delayed up to study Day 14), patients will rec
Other Name:Iodine-131 Anti-B1 Antibody

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Nebraska
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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