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A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
This study has been terminated.
( Vaccine unavailable. )

First Received on May 30, 2002.   Last Updated on March 25, 2011   History of Changes
Sponsor: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038415
  Purpose

The goal of this clinical research study is learn if a vaccine that contains the patient's own cancer cell immunoglobulin can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). This clinical trial is a dose escalation study in which the safety of this vaccine will be studied. This is a dose escalation study in which each patient will receive vaccine at one dose level. Patients will be injected with a fragment of Deoxyribonucleic acid (DNA) containing the sequence of their own immunoglobulin gene. Patients will be required to have their diagnosis of CLL and stage confirmed prior to initiating vaccination. After vaccination patients will receive clinical and immunologic evaluation, including both humoral and cellular responses. The investigator will be assessing the patient's immune response or whether the patient's body recognizes the DNA vaccine. In addition, side effects and reactions to the vaccine will be evaluated.


Condition Intervention Phase
Leukemia, Lymphocytic, Chronic
 Biological: CLL vaccine using DNA plasmid vector
 Phase I
Phase II

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 I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia
U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: Continuous reassessment up to 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: December 2001
Study Completion Date: January 2005
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine Biological: CLL vaccine using DNA plasmid vector

Detailed Description:

OBJECTIVES:

  1. To determine if patients with Binet Stage A CLL generate an immune response to an antigen delivered by a DNA vaccine.
  2. To determine if patients with Binet Stage A CLL generate an immune response to a tumor derived antigen delivered by a DNA vaccine.
  3. To determine the optimal dose of DNA vaccine to obtain anti-idiotype immune responses.
  4. To characterize any adverse effects of idiotypic vaccination with a DNA vaccine.
  5. To determine if DNA idiotypic vaccination is capable of inducing remission in Binet´s Stage A CLL.
  Eligibility

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

Inclusion Criteria:

  • Patients with Binet Stage A Chronic Lymphocytic Leukemia (CLL)
  • WHO performance status of 2 or less.
  • A life expectancy of at least one year.
  • Greater than 18 years of age.
  • Availability of CLL cells which can be used for DNA extraction and processing.
  • A platelet count greater than 100 x 109/l.
  • Ability to provide full informed consent.

Exclusion Criteria:

  • Previous chemotherapy or radiotherapy.
  • Presence of a monoclonal band on serum electrophoresis.
  • Presence of clinically significant levels of anti-DNA antibodies, anti-muscle antibodies or rheumatoid factors or who have active autoimmune disease.
  • Presence of antibodies to human immunodeficiency virus (HIV) and known carriers of hepatitis B or hepatitis C virus.
  • Presence of other serious medical condition e.g. congestive heart failure.
  • Presence of other malignancies.
  • Pregnancy, lactation, or not using contraceptive measures.
  • Concurrent use of other anti-cancer therapy.
  • Patients allergic to tetanus vaccine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038415

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Michael J. Keating, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Michael J.Keating, MD / Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038415     History of Changes
Other Study ID Numbers: DM99-412
Study First Received: May 30, 2002
Last Updated: March 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
CLL
Binet Stage A
Vaccination
 Idiotypic
Genetic
Deoxyribonucleic acid
DNA

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 12, 2012



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