Overview

Reactogenicity, Immunogenicity of Trivalent Influenza Vaccine With Recombinant Interferon Alpha Among Chronic Lymphocytic Leukemia

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical study is to learn if Pegasys (pegylated interferon) or Roferon (interferon) can make the Trivalent Inactivated Influenza vaccine (TIV) more effective in increasing the body's immune reaction against the flu virus in patients with Chronic Lymphocytic Leukemia (CLL).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Interferon alpha-2
Interferon-alpha
Interferons
Peginterferon alfa-2a
Vaccines
Criteria
Inclusion Criteria:

1. Capable of understanding the protocol requirements and risks and providing written
informed consent.

2. Patients with histologically or cytologically confirmed diagnosis of chronic
lymphocytic leukemia according to established guidelines.

3. Patients with Rai stages 0 to 4.

4. Age >/= 18 years old.

5. If patients have been treated with antineoplastic therapy, it must have been finished
3 months or longer prior to enrollment.

6. Patients with complete or partial remission and those with stable (CLL) disease will
be considered.

7. Patients who have received influenza vaccine in past 4 months will also be considered.

8. Patients willing to receive recombinant cytokine.

9. Patient willing to receive commercially available influenza vaccine that will not
provide protection against the following years of influenza strains.

10. Patients must have adequate hepatic function defined as follows: total bilirubin 2.0 mg/dL; SGOT and /or SGPT value unless liver function abnormalities are considered due to underlying cancer or
congenital hemolytic disorders.

11. Patient should avoid H2 blockers while on study. However, if H2 blockers are required
to use, this will be reported and will be taken in consideration during response rate
analysis.

12. Females patients who are able to have children must agrees to remain abstinent or use
(or have their partner use) 2 acceptable methods of birth control during the time
period starting 2 weeks prior to enrollment through 1 month from last vaccination
dose. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm
with spermicide, contraceptive sponge and condom. If they suspect pregnancy during the
study, they must notify the study doctor.

Exclusion Criteria:

1. Concurrent serious medical illness in the opinion of Principle Investigator that could
potentially interfere with protocol compliance.

2. Concurrent or previous malignancy whose prognosis is poor (< 90% probability of
survival is 5 years).

3. History of known chronic viral infections within 12 months, including HIV and
Hepatitis B or Hepatitis C. A screening for hepatitis or HIV will not be performed for
this study.

4. Positive screening pregnancy test within 2 weeks in non-menopausal women or
breast-feeding.

5. Patients with known allergy to either vaccine or interferon preparation.

6. Patients with neutropenia (ANC < 500 cells/uL) within 4 weeks.

7. Patients with lymphocytopenia (ALC < 300 cells/uL) within 4 weeks.

8. Concomitant use of investigational vaccines and/or medications within four weeks prior
to study entry, or expected use of experimental or licensed vaccines or blood/blood
products prior to study completion.

9. Receipt of immunoglobulin in 3 months.

10. Subject is enrolled in a conflicting clinical trial.

11. History of Guillain-Barre Syndrome.

12. Has an acute illness including an oral temperature greater than 100.4°F, within one
week of vaccination.

13. In patients who have prior therapy with fludarabine or alemtuzumab (Campath®), the
treatment must have completed 12 months prior to enrollment.

14. In patients who have prior therapy with Rituximab (Rituxan®), the treatment must have
completed 6 months prior to enrollment.

15. Patients with history of medically significant psychiatric disease, especially
endogenous depression (not reactive to diagnosis of cancer), psychosis and bipolar
disorder.

16. Patients with seizure disorders requiring anticonvulsant therapy.

17. Patients with history of severe cardiac disease with New York Heart Association (NYHA)
grade 3 or 4.

18. Patients with severe renal disease requiring hemodialysis.

19. Patients who have received H2 blockers such as Ranitidine, Cimetidine, or Famotidine
within 4 weeks prior to enrollment.