A Phase II Trial of Combined Weekly Bortezomib and Tositumomab I-131 in Patients With Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma

NCT00479167 | Terminated Phase 2 Results

• 1 other identifier: LYM 2005-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine what dose of bortezomib in combination with tositumomab I-131 is tolerable whether bortezomib and Tositumomab I-131 are effective in the treatment of relapsed or refractory non-hodgkin's lymphoma (NHL). Both agents are effective in treating relapsed and refractory NHL. Administer of the agents together may sensitize the cells to the radiation from Tositumomab I-131.

Conditions

Follicular Lymphoma

Keywords

Non-Hodgkin's Lymphoma; Follicular Non-Hodgkin's Lymphoma; Lymphoma

Outcome Measures

Primary Outcomes (1)

• The Primary Objective of This Study is to Determine the Maximum Tolerated Dose (up to 1.6 mg/m2) of Bortezomib Combined With Tositumomab and Iodine I 131 Tositumomab

  Study terminated.

Secondary Outcomes (1)

• To Further Explore the Toxicity and Efficacy of Bortezomib Combined With Tositumomab and Iodine I 131 Tositumomab and Assess the Tolerability of Bortezomib After Tositumomab

  Study Terminated.

Study Arms (1)

Bortezomib and Tositumomab I-131

EXPERIMENTAL

Drug: Bortezomib and Tositumomab I-131

Interventions

Bortezomib and Tositumomab I-131 DRUG

Bortezomib and Tositumomab I-131

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously treated or relapsed follicular lymphoma. One prior therapy required.
• Bi-dimensionally measurable disease with at least one lesion measuring \> 2.0 X 2.0cm by CT scan or evaluable disease.
• CD20+ at time of diagnosis or subsequently.
• Platelet count \> 100,000/uL, ANC \> 1000/uL.
• Transaminases less than two-fold normal range.
• Adequate renal function defined as \<1.5 X upper limit of normal
• HAMA negative
• ECOG performance status 0, 1, 2.
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• Male subject agrees to use an acceptable method for contraception for the duration of the study.
• Negative Hepatitis profile screening

You may not qualify if:

• Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
• Patient has hypersensitivity to boron or mannitol.
• Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens
• Hypocellular bone marrow (≤15% cellularity or marked reduction in bone marrow precursors).
• Prior myeloablative therapy.
• History of failed stem cell collection.
• Prior radiotherapy to fields encompassing more than 25% of the blood-forming marrow.
• Prior chemotherapy, biologic therapy, radiation therapy or steroid therapy for NHL within three weeks prior to screening procedures. Six weeks for nitrosureas. Subjects receiving low doses of steroids for non-neoplastic indications may enter the study ("low dose steroids" is defined as ≤10 mg of prednisone or equivalent per day).
• Prior Radioimmunotherapy or bortezomib.
• Prior malignancy other than lymphoma, except for adequately treated basal cell or squamous cell skin cancer, in situ uterine cervical cancer, or other cancer for which the subject has been disease-free for five years.
• Evidence of active infection requiring intravenous antibiotics at the time of study enrollment.
• Known HIV infection.
• Known brain or leptomeningeal metastases.
• Active obstructive hydronephrosis.
• Known Type I hypersensitivity or anaphylactic reactions to murine proteins or any component of the Iodine I 131 tositumomab therapeutic regimen.

Sponsors & Collaborators

• Rush University Medical Center: lead
• GlaxoSmithKline: collaborator
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (27)

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MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma

Interventions

Bortezomib; tositumomab I-131

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Only 1 patient was on study and withdrew after 1 cycle. There was lack of interest in the study. The PI is now retiring.

Results Point of Contact

• Title: Stephanie Gregory, MD
• Organization: Rush University Medical Center

stephanie_gregory@rush.edu

312-942-5982

Study Officials

• Stephanie A Gregory, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 28, 2007
• Study Start: May 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 4, 2021
• Results First Posted: November 4, 2021

Record last verified: 2021-10

Locations

US (1)