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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.
First Received: May 30, 2002   Last Updated: June 23, 2005   History of Changes
Sponsored by: 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 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

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach

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

Estimated Enrollment: 25
Study Start Date: December 2001
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 characterise 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:

  • Patients with Binet Stage A 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:

  • 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 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
  More Information

No publications provided

Study ID Numbers: DM99-412
Study First Received: May 30, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00038415     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Lymphatic Diseases
Leukemia
Chronic Lymphocytic Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
 Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, Chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

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

ClinicalTrials.gov processed this record on May 07, 2009



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