Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer
| Status: | Suspended |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2012 |
A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage I-IV Breast Cancer
Despite advances in surgical, radiation and medical therapies of early stage breast cancer,
some patients will experience disease recurrence. Because recurrence may not happen for
years after definitive treatment, there is a period of time between resection and relapse
when micrometastatic disease may be amenable to immune eradication or modulation. While the
ultimate goal of any cancer treatment is clinical efficacy, the immediate urgency in breast
immunotherapy is to define treatments that have immunologic efficacy. In this study, the
investigators will determine whether a vaccine consisting of nine-class I breast specific
peptides plus a class II tetanus toxoid helper peptide is immunogenic when administered with
poly-ICLC to participants with stage IB to IIIA breast cancer in the adjuvant setting.
some patients will experience disease recurrence. Because recurrence may not happen for
years after definitive treatment, there is a period of time between resection and relapse
when micrometastatic disease may be amenable to immune eradication or modulation. While the
ultimate goal of any cancer treatment is clinical efficacy, the immediate urgency in breast
immunotherapy is to define treatments that have immunologic efficacy. In this study, the
investigators will determine whether a vaccine consisting of nine-class I breast specific
peptides plus a class II tetanus toxoid helper peptide is immunogenic when administered with
poly-ICLC to participants with stage IB to IIIA breast cancer in the adjuvant setting.
The study is a single arm, open label, pilot study of safety and immune efficacy of peptide
vaccination with poly-ICLC in patients with stage IB-IIIA resected breast cancer.
Participants will be patients who have completed their last dose/treatment of any single
treatment or combination of adjuvant surgery, radiation, chemotherapy or trastuzumab therapy
between 45 days and 6 months (180 days) prior to enrollment.
Each vaccination will be administered on days 1, 8, 15, 36, 57, and 78. All participants
will receive 9 class I MHC-restricted synthetic peptides (restricted by HLA-A1, -A2, -A3, or
-A31) and a class II MHC-restricted tetanus helper peptide mixed with 1mg poly-ICLC and
administered in sterile water. The vaccine will be administered intramuscular (IM) (1 ml)
and intradermally (ID) (1 ml) at vaccination sites in the arm and leg. (Each vaccine given
IM and ID at one site; site to alternate between arm site opposite the breast cancer and an
anterior thigh site.) Participants will be screened for HLA type and must be HLA-A1, -A2,
-A3, or -A31 (80% of the Virginia population in prior studies1).
Annual follow-up for progression and survival for 3 years after study withdrawal/completion.
vaccination with poly-ICLC in patients with stage IB-IIIA resected breast cancer.
Participants will be patients who have completed their last dose/treatment of any single
treatment or combination of adjuvant surgery, radiation, chemotherapy or trastuzumab therapy
between 45 days and 6 months (180 days) prior to enrollment.
Each vaccination will be administered on days 1, 8, 15, 36, 57, and 78. All participants
will receive 9 class I MHC-restricted synthetic peptides (restricted by HLA-A1, -A2, -A3, or
-A31) and a class II MHC-restricted tetanus helper peptide mixed with 1mg poly-ICLC and
administered in sterile water. The vaccine will be administered intramuscular (IM) (1 ml)
and intradermally (ID) (1 ml) at vaccination sites in the arm and leg. (Each vaccine given
IM and ID at one site; site to alternate between arm site opposite the breast cancer and an
anterior thigh site.) Participants will be screened for HLA type and must be HLA-A1, -A2,
-A3, or -A31 (80% of the Virginia population in prior studies1).
Annual follow-up for progression and survival for 3 years after study withdrawal/completion.
Inclusion:
- Patients who have been diagnosed with clinical or pathologic stage I to stage IV
adenocarcinoma of the breast (any subtype) who have undergone, and recovered from
primary therapy (any combination of surgery, radiation, and/or chemotherapy and/or
HER2-directed therapy), with their last dose/treatment (of any single or combination
treatment) being between 28 days and 36 months prior to enrollment. Staging will be
based on the Seventh Edition AJCC staging system. (Systemic staging with CT or PET
scans is not required by AJCC and is not required or exclusionary for this trial).
- Stage IA patients must be high risk based upon triple negative status or HER2+ status
- Patients may or may not be receiving hormonal therapy at the time of study entry.
- Age ≥ 18 years at the time of enrollment
- ECOG performance status of 0 or 1
- Ability and willingness to give informed consent
- HLA-A1, -A2, -A3, or -A31 positive
- Adequate organ function
- HIV and Hepatitis C negative
- Subjects must have a minimum of two intact lymph node basins (any combination of
axillary and inguinal basins that have not undergone complete nodal dissection)
Exclusion Criteria
- Known or suspected allergies to any component of the vaccine
- Active infection requiring antibiotics are excluded.
- The following medications or treatments within the 4 weeks (28 days) prior to
consenting. These medication and treatments may not be re-started at any time
throughout the study in order to remain eligible.
- Breast tumor resection surgery (reconstructive surgery permitted)
- Chemotherapy
- Radiation therapy
- Allergy desensitization injections
- Growth factors (e.g., Procrit®, Aranesp®, Neulasta®)
- Other agents with putative immunomodulating activity (with the exception of
non-steroidal anti-inflammatory agents)
- Any investigational medication
- Tthe following medications or treatments within the 4 weeks (28 days) prior to
consenting:
- Corticosteroids, administered parenterally, orally, or inhaled (Inhaled
steroids, such as: Advair®, Flovent®, Azmacort.®)
- Topical corticosteroids are acceptable.
- Previous vaccination with any of the synthetic peptides included in this protocol.
- Active tuberculosis and not on active antitubercular agents
- Pregnancy.
- Female subjects must not be breastfeeding
- A medical contraindication or potential problem in complying with the requirements of
the protocol, in the opinion of the investigator
- New York Heart Association classification as having Class III or IV heart disease
- Stage IV subjects who have anticipated chemotherapy need within the 108 day treatment
period for this trial.
- Subjects that have experienced active autoimmune disorders requiring cytotoxic or
immunosuppressive therapy within the 6 weeks (42 days) prior to consenting.
- The following will not be exclusionary:
- The presence of laboratory evidence of autoimmune disease (e.g., positive
ANA titer) without symptoms
- Clinical evidence of vitiligo
- Other forms of depigmenting illness
- Mild arthritis requiring NSAID medications
We found this trial at
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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