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

This study has been terminated.

(Vaccine unavailable.)

Sponsor:

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT00038415

First received: May 30, 2002

Last updated: August 1, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 30, 2002

Last Updated Date

August 1, 2012

Start Date ^ICMJE

December 2001

Primary Completion Date

July 2004 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum Tolerated Dose (MTD) [ Time Frame: Continuous reassessment up to 1 year ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00038415 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

OBJECTIVES:

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Leukemia, Lymphocytic, Chronic

Intervention ^ICMJE

Biological: CLL vaccine using DNA plasmid vector

Study Arms

Experimental: Vaccine

Intervention: Biological: CLL vaccine using DNA plasmid vector

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2005

Primary Completion Date

July 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00038415

Other Study ID Numbers ^ICMJE

DM99-412

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

M.D. Anderson Cancer Center

Study Sponsor ^ICMJE

M.D. Anderson Cancer Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael J. Keating, MD

UT MD Anderson Cancer Center

PRS Account

M.D. Anderson Cancer Center

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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