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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Bayer
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00323557

Purpose

The goal of this clinical research study is 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).

Condition	Intervention	Phase
Leukemia	Drug: Sargramostim (GM-CSF) Biological: Pneumococcal Vaccine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Immuno-Augmentation With GM-CSF in Patients Receiving Pneumococcal Vaccine While Undergoing Treatment for Advanced Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia Pneumonia

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

U.S. FDA Resources

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

Primary Outcome Measures:

Patient Immune Response to GM-CSF with a pneumococcal vaccine [ Time Frame: Anti-pneumococcal immunoglobulin titers measured at baseline and at 1 month after vaccine. ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	June 2004
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pneumococcal Vaccine + Sargramostim 3 Doses of 250 mg subcutaneously, at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine).	Drug: Sargramostim (GM-CSF) Starting with 3 doses of 250 micrograms subcutaneously, days -7 (+ 1 day) and -3 (+ 1 day), in the week prior to vaccination for pre-vaccination immune priming; 3rd dose on the day of vaccination (day 0). Other Names: Leukine GM-CSF Granulocyte macrophage colony stimulating factor - Biological: Pneumococcal Vaccine Subcutaneously on Day 0 Other Name: Prevnar
Experimental: Pneumococcal Vaccine Alone First vaccine dose subcutaneously, Day 0.	Biological: Pneumococcal Vaccine Subcutaneously on Day 0 Other Name: Prevnar

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:

1) Patients in complete / partial remission or those with active CLL with Rai stage 0 to 4.

Exclusion Criteria:

Patients will not be entered while neutropenic (PMNs < 500 cells/mm3) or having received Rituximab within 6 months.
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
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Bayer

Investigators

Principal Investigator:

Amar Safdar, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

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

No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:	Amar Safdar, MD/Associate Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00323557 History of Changes
Other Study ID Numbers:	2003-0605
Study First Received:	May 5, 2006
Last Updated:	August 9, 2011
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

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