Cancer
Conditions
Brief summary
This research study is for people who have previously received cancer vaccines. The investigators are testing a form of therapy known as interferon alfa-2a, which is commercially available as the drug Roferon®-A, to see if it can be used to help boost the effects of the cancer vaccine and help the immune system attack the cancer. It is believed that the body's immune system can attack tumor cells and kill them. This is thought to be due to immune cells called T cells which can recognize special proteins on the surface of tumors as a signal to fight the cancer. However, the vaccine may not work very well if the protein signal is too weak for the T cells to find your tumors. The investigators think that interferon alfa-2a can signal the cancer cells in the body to make more proteins that may allow the T cells to recognize and kill the cancer cells better.
Interventions
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have received a cancer vaccine targeting tumor antigen. * 6 months following the last dose of the prior vaccine. * Measurable disease defined by the RECIST criteria (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT.) * Karnofsky performance status greater than or equal to 70% * Estimated life expectancy \> 6 months. * Age ≥ 18 years. * Adequate, hematologic function with: * WBC ≥ 3000 mm3 * hemoglobin ≥ 9 mg/dL (may transfuse or use erythropoietin to achieve this level) * platelets ≥ 100,000/mm3 * Adequate, renal and hepatic function with: * serum creatinine \< 2.5 mg/dL * bilirubin \< 2.0 mg/dL * SGOT/SGPT \< 1.5 x upper limit of normal * No prior grade 3 or 4 major organ or allergic toxicity attributable to the prior vaccine * Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines. * Ability to return to Duke University Medical Center for adequate follow-up, as required by this protocol.
Exclusion criteria
* Patients with concurrent chemotherapy, radiation therapy, or immunotherapy should be excluded. Patients may not have received interferon previously. * Patients with either previously irradiated or new CNS (central nervous system) metastases at entry are excluded. Pre-enrollment head CT is not required if not indicated by clinical signs or symptoms. * Patients with a history of auto-immune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. * Patients with serious intercurrent chronic or acute illness, such as cardiac disease, (NYHA class III or IV), hepatic disease, or other illness considered by the PI as unwarranted high risk for investigational drug treatment. * Patients with a medical or psychological impediment to probable compliance with the protocol. * Concurrent second malignancy other than non-melanoma skin cancer, or controlled superficial bladder cancer. * Presence of an active acute or chronic infection including: an urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology). HIV patients are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections. * Patients on steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment. * Patients with egg allergies or allergies to any component of the vaccine should be excluded from the protocol. * Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control in order to be in this study. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that maybe fathered while on this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Clinical Responders (Complete Response + Partial Response) | 4 weeks | Response determination will be made according to the RECIST criteria. Complete response defined as the disappearance of target lesion, confirmed at 1-4 weeks. Partial response defined as 30% decrease in longest dimension of target lesion, confirmed at 1-4 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Experiencing an Increase in the Magnitude of the Tumor Antigen-specific Immune Response | 4 weeks | The proportion of patients experiencing an increase in the magnitude of the tumor antigen-specific immune response following the administration of interferon will also be estimated. Immune response will be determined by ELISPOT analysis. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interferon-alfa-2a Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.
Interferon Alfa-2a | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Interferon-alfa-2a |
|---|---|
| Age, Customized 18 years and older | 11 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Proportion of Clinical Responders (Complete Response + Partial Response)
Response determination will be made according to the RECIST criteria. Complete response defined as the disappearance of target lesion, confirmed at 1-4 weeks. Partial response defined as 30% decrease in longest dimension of target lesion, confirmed at 1-4 weeks.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interferon-alfa-2a | Proportion of Clinical Responders (Complete Response + Partial Response) | 0 percentage of participants |
Secondary
Proportion of Patients Experiencing an Increase in the Magnitude of the Tumor Antigen-specific Immune Response
The proportion of patients experiencing an increase in the magnitude of the tumor antigen-specific immune response following the administration of interferon will also be estimated. Immune response will be determined by ELISPOT analysis.
Time frame: 4 weeks
Population: Five subjects analysed due to one subject not completing blood draws.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interferon-alfa-2a | Proportion of Patients Experiencing an Increase in the Magnitude of the Tumor Antigen-specific Immune Response | 60 percentage of participants |