Leptomeningeal Disease, Triple Negative Breast Cancer, HER2-positive Breast Cancer
Conditions
Brief summary
The purpose of this study is to learn about the effects of the study treatment, Dendritic Cell Vaccine (DCV), to find the highest dose of the study treatment that can be given safely to Breast Cancer patients with Leptomeningeal Disease
Interventions
BIOLOGICALDendritic Cell Vaccine
Intrathecal (IT) dendritic cell vaccine (DCV) will be administered once every week. As per standard procedures of IT chemotherapy or antibody administration it is administered over 5 -10 minutes or at 1 ml/minute while monitoring the patient under sterile conditions. In general, to assure delivery of the DCVs into the ventricular space and compensate for "dead space" in the Ommaya, the delivery of IT DCV cells is followed by the administration of 2.5 mls of saline. In general there is a maximum volume of 10 mls of DCVs.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
United States Department of Defense
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
* Histologically or cytologically confirmed diagnosis of TNBC or HER2+BC per ASCO/CAP guidelines . A tumor can be considered a TNBC if the ER or PR is \<10%. * Trial participants must have a diagnosis of LMD. They must have the presence of malignant cells in the CSF (CSF+; note now cytology is considered diagnostic of LMD if the cytology is read as positive or suspicious; OR characteristic radiographic abnormalities (see below) of LMD). Signs and symptoms of LMD in and of themselves are not sufficient for inclusion. * Patients must have an Eastern Cooperative Oncology Group performance scale of ≤ 3. * Coincident Brain or Spinal cord metastases are allowed if these are stable and do not require local therapy at the time of enrollment. Individuals with previously treated stable Brain metastases are eligible to participate. * Stereotactic Radiosurgery (SRS) and/or prior radiotherapy is permitted \> 2 weeks prior to initial Dendritic Cell (DC) vaccine dose. A follow up brain MRI should be obtained prior to DC vaccine to determine stability of the lesions. An interval of at least 4 weeks after the end of whole brain radiation or for any surgical resection of brain lesions is permitted. * Life expectancy of ≥ 8 weeks. * Demonstrate adequate organ function as defined in protocol. All screening labs should be performed with 14 days of treatment initiation. * Provision of signed and dated informed consent form. * Corticosteroids at doses equivalent to 8 mg dexamethasone daily for symptom control are acceptable. This should be minimized wherever possible. * If the disease has progressed on current treatment in the CNS prior to consent, patients may continue current systemic cancer therapies as per PI discretion (Systemic Therapies Allowed) and
Exclusion criteria
. Patients should not start a new anti-cancer agent until the 28 day safety period is completed. * Patients with systemic disease are eligible and will be managed as detailed in Section 6.3.1. * Pregnancy test: negative serum or urine pregnancy test at screening for women of childbearing potential. Must be repeated once-monthly during treatment. Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 90 days after last treatment administration, if the risk of conception exists. * The patient has an Ommaya reservoir or equivalent device which allows routine access to CSF and administration of DC1s.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose of Intrathecal Dendritic Cell Vaccine | Up to 12 weeks | Maximum tolerated dose of intrathecal dendritic cell vaccine is defined as the highest dose of vaccine that does not cause undesirable side effects/dose limiting toxicity (DLT). To evaluate safety, the study team will monitor toxicities continuously and the study will be halted if an excessive number of toxicities are encountered. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 12 months | Overall Survival (OS) will be measured from the initial date of treatment to the recorded date of death. |
| Progression Free Survival | Up to 12 months | Progression Free Survival defined as the time from start of treatment to the time of progression or death. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPeter A Forsyth, MD
Moffitt Cancer Center
Outcome results
None listed