Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Bayer
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00323557

Purpose

Primary Objective:

1. To evaluate efficacy of GM-CSF-mediated enhanced seroconversion (protective anti-pneumococcal serum immunoglobulins) in patients receiving conventional 23-valent capsular polysaccharide pneumococcal vaccine (PPV) and 7-valent Pneumococcal conjugated vaccine (PCV7) while undergoing treatment for advanced chronic lymphocytic leukemia (CLL).

Secondary Objective:

1. To evaluate the effect of GM-CSF on the dendritic cells and cytokine production in CLL patients.

Condition	Intervention	Phase
Leukemia	Drug: Sargramostim Biological: Pneumococcal Vaccine	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Pneumonia

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Immuno-Augmentation With GM-CSF in Patients Receiving Pneumococcal Vaccine While Undergoing Treatment for Advanced Chronic Lymphocytic Leukemia (CLL)

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

Primary Outcome Measures:

To see if Leukine(R) (sargramostim) improves the effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia, in patients with chronic lymphocytic leukemia (CLL). [ Time Frame: 4.5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	June 2004
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pneumococcal Vaccine + Sargramostim	Drug: Sargramostim 250 micrograms subcutaneously at the same time receive the pneumococcal vaccine. Biological: Pneumococcal Vaccine Subcutaneously on Day 1 and 6 Weeks after the First Vaccine Dose
2: Experimental Pneumococcal Vaccine Alone	Biological: Pneumococcal Vaccine Subcutaneously on Day 1 and 6 Weeks after the First Vaccine Dose

Detailed Description:

Sargramostim (also commonly called granulocyte macrophage colony stimulating factor - GM-CSF) is a medication used to stimulate the bone marrow production of white blood cells before a stem cell transplant, after chemotherapy or after a bone marrow transplant. Pneumococcal vaccine is a medication used to prevent infections caused by a bacteria called Streptococcus pneumoniae.

If you have not had a gammaglobulins test (a test to measure immunity against certain infectious diseases) measured within three months before the study begins, then this blood test will be done before you receive any study medications.

Women who are able to have children must have a negative urine pregnancy test before starting treatment.

After consenting to this study, you will be randomly assigned(as in the toss of a coin) to receive treatment with sargramostim in addition to the pneumococcal vaccine or to receive pneumococcal vaccine alone (Prevnar).

If you are randomized to vaccine plus sargramostim group, you will receive an injection of sargramostim at the same time you receive the pneumococcal vaccine.

If you are randomized to the vaccine alone group, you will receive the pneumococcal vaccine on the first day.

Blood tests will be performed on the day of the pneumococcal vaccination, and 4 weeks, 12 weeks and 24 weeks after vaccination. Each of the blood tests will require about 4 teaspoons of blood. These blood tests will measure your immunity to pneumococcal infection.

If after 6 months of your first vaccination your body is not able to show immunity to pneumococcal infection, you will receive a second dose either pneumococcal vaccine plus sargramostim or pneumococcal vaccine alone. Your immunity will be checked again at 4 weeks, 12 weeks, and 24 weeks after this second dose. Only 4 teaspoon of blood will be required for the tests.

You may be removed from the study if you have a severe allergic reaction to the sargramostim and/or pneumococcal vaccine. The total maximum time you will be on this is study is 24 months.

This is an investigational study. Both of the medications used in this study are approved by the FDA. Up to 50 patients may be treated on this study. All will be enrolled at M.D. Anderson.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with Rai stage (0 to 4) CLL.
No prior Campath or fludarabine-based therapy within 12 months.
No prior Rituximab® within 6 months.

Exclusion Criteria:

Patients will not be entered while neutropenic (PMNs < 500 cells/mm3).
Patients will not be entered while febrile (T > 38 degrees C) within 1 week.
Active infection.
Patients with known HIV infection.
Known history of allergy to GM-CSFor pneumococcal vaccine.
Chemotherapy other than Campath, fludarabine, cyclophosphamide, in 4 weeks.
Patients who have previously received pneumococcal vaccine within the preceding 12 months.
Absolute lymphocyte count less than 500 cells/mm3

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323557

Locations

United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Bayer

Investigators

Principal Investigator:

Amar Safdar, MD

U.T.M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Safdar A, Rodriguez GH, Rueda AM, Wierda WG, Ferrajoli A, Musher DM, O'Brien S, Koller CA, Bodey GP, Keating MJ. Multiple-dose granulocyte-macrophage-colony-stimulating factor plus 23-valent polysaccharide pneumococcal vaccine in patients with chronic lymphocytic leukemia: a prospective, randomized trial of safety and immunogenicity. Cancer. 2008 Jul 15;113(2):383-7.

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Amar Safdar, MD/Associate Professor )
Study ID Numbers:	2003-0605
Study First Received:	May 5, 2006
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00323557
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Chronic Lymphocytic Leukemia
Leukemia
Sargramostim
Pneumococcal Pneumonia

Pneumococcal Vaccine
Prevnar
GM-CSF
CLL

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, B-cell, chronic
Pneumonia, Pneumococcal
Lymphoproliferative Disorders
Leukemia, B-Cell
Pneumonia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009