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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Millennium Pharmaceuticals, Inc.
Information provided by:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00479167
First received: May 24, 2007
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Follicular Lymphoma
Drug: Bortezomib and Tositumomab I-131
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Combined Weekly Bortezomib and Tositumomab I-131 in Patients With Relapsed or Refractory Follicular Non-Hodg

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 20
Study Start Date: May 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • Patient has received other investigational drugs with 14 days before enrollment
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Patient has Grade 2 peripheral neuropathy within 14 days before enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479167

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
GlaxoSmithKline
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Stephanie A Gregory, MD Rush University Medical Center
  More Information

Publications:

Responsible Party: Dr. Stephanie Gregory, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00479167     History of Changes
Other Study ID Numbers: LYM 2005-01
Study First Received: May 24, 2007
Last Updated: February 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Rush University Medical Center:
Non-Hodgkin's Lymphoma
Follicular Non-Hodgkin's Lymphoma
Lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Iodine-131 anti-B1 antibody
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014