BEAM+131I-Anti-B1 & Autologous Hematopoietic Stem Cell Transplant for Recurrent Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00574509
First received: December 12, 2007
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to assess the safety of 131I-anti-B1 Radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy and hematopoietic stem cell transplantation. The study will also compare the difference in response rates and time to treatment failure between historical control patients receiving high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem cell transplant and patients receiving radioimmunotherapy and high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem cell transplant. Patients will receive escalating doses of radioimmunotherapy with anti-B1 radiolabeled with 131Iodine, high-dose carmustine, etoposide, cytarabine and Melphalan (BEAM) chemotherapy, and autologous hematopoietic stem cell transplant.


Condition Intervention Phase
Lymphoma
Radiation: 131Iodine-Anti-B1 Radioimmunotherapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BEAM + 131Iodine-Anti-B1 Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Recurrent Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Safety of 131I-anti-B1 radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy & HSCT [ Time Frame: During treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Difference in response rates & time to tx failure between historical control patients receiving high-dose BEAM or BEAC chemo. with autologous HSCT and pateints receiving radioimmunotherapy and high-dose BEAM or BEAC chemo. with autologous HSCT [ Time Frame: time of registration to time of treatment discontinuation ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: March 1996
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 131I-Anti-B1
BEAM + 131Iodine-Anti-B1 radioimmunotherapy and autologous HSCT
Radiation: 131Iodine-Anti-B1 Radioimmunotherapy
Dosimetric dose of 450 mg unlabeled Anti-B1 followed by 35 mg Anti-B1 which has been trace labeled with 5mCi of 131I-Anti-B1.
Other Name: 131Iodine-Anti-B1 Radioimmunotherapy

Detailed Description:

Thirty patients will be enrolled in this study. There will be two administrations of 131I-anti-B1 given to patients, the "dosimetric dose" and the "radioimmunotherapy dose". The dosimetric dose will consist of an infusion of unlabeled Anti-B1 (450 mg) immediately followed by an infusion of Anti-B1 (35 mg) which has been trace labeled with 5mCi of 131I-anti-B1. The total whole body dosimetry dose is then calculated over an approximated one-week time interval from the radioactive clearance data obtained by the Whole Body anterior and posterior gamma camera scans. Based upon dosimetric data calculations specific for each individual patient, a radioimmunotherapy dose will be given consisting of an infusion of unlabeled Anti-B1 (450 mg)immediately followed by an infusion of 35 mg Anti-B1 including a patient specific dose of 131Iodine-Anti-B1. Calculations will be made such that in a dose escation study, whole body radiation doses of 30, 45, 60, and 75cGy will result from the administration of the therapeutic activity of 131I-anti-B1. The amount of the unlabeled Anti-B1 administered is not calculated on a body surface area basis, but is given to provide an excess of Anti-B1 independent of tumor burden, splenic uptake, or other causes.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pts with a diagnosis of indolent or aggressive B-cell non-Hodgkin's lymphoma who have failed > 3 prior therapies, or are chemo resistant or refractory. Patients must be otherwise eligible for high-dose therapy with the BEAM protocol and ABMT or PSCT.
  • Pts without evidence of severe organ dysfunction.
  • The pre-transplant bone marrow biopsy must show no evidence of marrow involvement if an autologous BMT is to be performed and adequate cellularity, alternatively autologous PSCT will be considered if the bone marrow involvement is <25%.
  • The pt must have no other major medical problems and specifically life expectancy must be at least 4 months post transplant, with a performance status Karnofsky score of >70.
  • Pts with evidence that their tumor tissue expresses the CD20 antigen. Immunoperoxidase stains of tissue showing positive reactivity with L26 antibody or flow cytometry studies are acceptable evidence of CD20 positivity. Testing of tumor tissue from any time in the course of the patient's disease is acceptable.
  • Pts must have normal renal function (creatinine < 2.0 mg/dL) and hepatic function (bilirubin < 2.0 mg/dL) within seven days of study entry.
  • Pts with DLCO >50% of predicted.
  • If pt is >60 years or has a significant cardiac history (MI or CHF) or has received >350 mg/m2 of Adriamycin and ejection fraction must be >40%.
  • Pts must give written informed consent and sign an approved informed consent form prior to study entry.
  • ts must have bidimensionally measurable disease.
  • Females of child-bearing potential must have a negative serum pregnancy test prior to enrollment to the study, followed by the use of an effective method of birth control.

Exclusion Criteria:

  • Pts with more than 25% of the intratrabecular marrow space involved by lymphoma in a unilateral bone marrow biopsy specimens as assessed microscopically prior to study entry.
  • Pts who have received cytotoxic chemotherapy, radiation therapy or immunosuppressants within THREE weeks prior to the radioimmunoconjugate dose or who exhibit persistent clinical evidence of toxicity. The use of steroids must have been discontinued (except maintenance-dose steroids).
  • Pts with obstructive hydronephrosis.
  • Pts with evidence of active infection requiring intravenous antibiotics at the time of study entry.
  • Pts with New York Heart Association class 3 or 4 heart disease or other serious illness that would preclude evaluation.
  • Pts with prior malignancy other than lymphoma, except for adequately treated skin ca, in situ cervical ca, or other ca for which patient has been disease-free for 5 years.
  • Pts with known HIV infection.
  • Pts with known brain or leptomeningeal metastases.
  • Pts who are pregnant. Patients of child-bearing potential must undergo a pregnancy test. Males and females must agree to use effective contraception during the study and females must continue effective contraception for one year following the radioimmunotherapy dose.
  • Pts with previous allergic reactions to iodine. This does not include IV contrast materials.
  • Pts who previously received radioimmunotherapy.
  • Pts with progressive disease in a field that has been previously irradiated with more than 3500 cGy within the past year.
  • Pts who are on another protocol involving non-FDA approved drugs or biologics.
  • No vulnerable subjects will be entered into this study.
  • Pts with a positive HAMA test at baseline will not be entered. Patients with a positive HAMA test at the end of the week following dosimetric dose administration may not continue on to receive the radioimmunotherapy dose without first contacting the FDA.
  • Pts who have not harvested a minimum CD34+ count of 1.5 X 10 6/kg body weight or CFU-GM count of >2.5 X 10 4/kg may not continue onto receive the study treatment.
  • Pts with prior HSCT following high-dose chemo or chemo/radiotherapy.
  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: NCT00574509

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Julie M Vose, MD University of Nebraska
  More Information

No publications provided

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT00574509     History of Changes
Other Study ID Numbers: 165-96
Study First Received: December 12, 2007
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Nebraska:
NHL
Non Hodgkins Lymphoma
131Iodine-Anti-B1 Radioimmunotherapy
Autologous Hematopoietic Stem Cell Transplant
AHSCT

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Iodine
Iodine-131 anti-B1 antibody
Anti-Infective Agents
Anti-Infective Agents, Local
Antineoplastic Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on October 29, 2014