Researchers are seeking participants for a Phase II clinical trial that will explore whether an investigational treatment can help the immune system recover after cancer treatment.
Cancer treatments such as chemotherapy and radiation therapy often deplete the immune system. Recovery takes time, particularly for older patients, and may not be complete. This can worsen the decline in immune function that occurs naturally with aging. Poor immune system recovery may also have a negative effect on the outcome of cancer treatment.
IL-7 is a protein that stimulates the growth and function of certain types of immune cells. To explore the effect of recombinant human IL-7 (rhIL-7) on immune system recovery and response to vaccines given to older patients after cancer treatment, researchers are conducting a Phase II clinical trial among people age 60 or older who have recently completed chemotherapy for non-metastatic breast cancer, colon cancer, or bladder cancer.
In addition to rhIL-7, study participants will receive routine vaccinations such as diphtheria/tetanus, PCV (pneumococcal), and influenza. Study participants will receive two groups of immunizations 7 weeks apart. Vaccine responses will be assessed several times during the first year. Treatment will be provided on an outpatient basis at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland.
The purpose of this trial is not to treat the cancer. All cancer-specific care will continue to be provided by the patient’s oncologist.
More information about this study (including additional eligibility criteria and contact information) is available at https://bethesdatrials.cancer.gov/clinical-research/faq.aspx?ProtocolID=NCI-11-C-0146.
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