Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Breast Neoplasms, Male

Breast Diseases

Skin Diseases

Breast Cancer, Male

All Drugs and Chemicals

Vaccines

Immunologic Factors

Participants currently enrolled into arm A will offered randomization into arms C or D. If study participants decline randomization or are ineligible, they will complete study follow up visits as stated in the schedule of events per Arm A.

A history and physical exam will be taken at 3-month intervals. Any changes in history or physical condition will be documented. Patient currently enrolled into arm B will offered randomization into arms C or D once finished with arm B. If patients decline randomization or are ineligible, they will complete study follow up visits as stated in the schedule of events per Arm B.

A history and physical exam will be taken at 3-month intervals. Any changes in history or physical condition will be documented

A history and physical exam will be taken at 3-month intervals. Any changes in history or physical condition will be documented.

Ultrasound (US) guided intranodal delivered vaccines will be administered at each participating site by a radiologist experienced in ultrasound guided procedures along with the principal investigator or his/her designee. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1 right and 1 left normal groin lymph nodes.

HER2 DC1 Vaccine

Ricardo Costa, M.D.

The purpose of this study is to learn more about how to treat patients with a diagnosis of diagnosis of Human Epidermal Growth Factor Receptor 2/neu (HER-2/neu) positive breast cancer in the past, who were previously treated with HER-2/neu-directed dendritic cells (DC) vaccines.

There is evidence that the use of anti-HER2 dendritic cell (DC) study vaccines could improve response to breast cancer therapy and be an important step in the prevention of recurrence.

This study will use a Dendritic Cell Type 1 (DC1) vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. Dendritic cells are immune cells that can tell the participant's immune system to fight infection. This study vaccine will be made from the participant's blood cells collected from a procedure called leukapheresis.

Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1

Immune Response Surveillance and Potential Booster Vaccines for Patients Who Have Received HER2-pulsed DC1 Vaccine

Investigators will assess the feasibility of participants receiving the six-booster regimen if 11/15 randomized to Arm D complete all 6 booster injections.

To compare the overall average effects of two different vaccine regimens on anti-HER2 CD4 immunity (ELISPOT) at 18 months from month 1 injection. treatment among women with breast cancer previously treated with HER2 vaccines. Two regimens consist of 3 versus 6 booster HER2 vaccine injections administered every 3 months

To compare the overall average effects of two different vaccine regimens on anti-HER2 CD4 immunity (ELISPOT) at month 10 from first vaccine treatment

Serious adverse events will be recorded for 100 days after study treatment. Adverse events will follow National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

OS will be measured using the Kaplan-Meier method

DFS will be measured using the Kaplan-Meier method

PFS will be measured using the Kaplan-Meier method

H. Lee Moffitt Cancer Center and Research Institute

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Lipid Regulating Agents

Herbal and Botanical

Red yeast rice

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

Red Yeast

Two RYR capsules three times daily for a minimum of 6 months

Marlene Kebabdjian, BA

Laurence Klotz, Md

Laurence Klotz, MD

Agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon cholesterogenesis. Red yeast rice (RYR), is a reddish-purple fermented rice, containing statins which are known to inhibit cholesterol synthesis. Laboratory studies have also shown that RYR has direct effects on androgen dependent and androgen independent prostate cancer cells, inhibiting their growth. It is thought that RYR may have clinical benefit in those subjects with localized prostate cancer who have chosen to be managed by active surveillance.

Red yeast rice has been promoted as a safe and effective alternative to statin therapy in the treatment of hypercholesterolemia. Red yeast rice has the potential to slow prostate cancer growth by inhibiting cholesterol and androgen biosynthesis. There is a strong rationale for the use of RYR in patients being managed with active surveillance for localized, low risk, prostate cancer. To date, no human studies utilizing RYR in this setting have been reported.

Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance

A Prospective Study of Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance

Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy

Determine effect of red yeast rice daily therapy on PSA kinetics in men on active surveillance for localized prostate cancer

To evaluate the effect of red yeast rice daily therapy on grade and the presence of prostatic intraepithelial neoplasia (PIN) in post treatment biopsy

To assess the effect of red yeast rice therapy on the expression of high sensitivity C-reactive protein (hs-CRP) and cardiac C-reactive protein (CRP) in serum

Dr. Laurence Klotz

Principal Investigator

Symptoms and General Pathology

Immune System Diseases

Recurrence

Hypersensitivity

Antineoplastic Agents

Androgens

Molgramostim

Sargramostim

Immunomodulating Agents

Subjects received infusion of Sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Subjects received infusion of control (autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen) at 2-week intervals, for a total of 3 infusions.

Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen.

Control

Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

Sipuleucel-T

Robert Israel, MD

The PROTECT-PROvenge Treatment and Early Cancer Treatment trial was a Phase III trial for patients with hormone sensitive prostate cancer. The study was conducted at over 15 participating centers throughout the US. The purpose of the study was to determine if sipuleucel-T was effective for treatment of early stage, non-metastatic prostate cancer. The study compared the active vaccine to control to determine whether the product delayed the time until cancer progression.

This was a prospective, double blind, controlled, randomized trial of immunotherapy with prostatic acid phosphatase (PAP)-loaded autologous antigen presenting cells (APCs), in subjects with non metastatic prostate cancer. Subjects that qualified for this study were men who had previously undergone a prostatectomy and whose only sign of disease recurrence was a rise in serum prostate specific antigen (PSA).

The primary objectives were to compare the time to biochemical failure (BF, PSA greater than or equal to 3 ng/mL) between sipuleucel-T (treatment group) and control, and to study the safety of sipuleucel-T.

Following short-term open-label treatment with a luteinizing hormone-releasing hormone-analogue (LHRH-a), Subjects completed a checklist designed to compare androgen suppression-related side effects during periods with and without androgen suppression.

Subjects who achieved a PSA of \< 1 ng/ml were randomized to blinded treatment assignments of either sipuleucel-T or control in a 2:1 ratio. Following randomization, subjects underwent 3 leukapheresis procedures on alternate weeks (Weeks 0, 2, and 4). Approximately three days following each leukapheresis procedure, subjects received an infusion of either sipuleucel-T or control.

At the time BF was confirmed, subjects were eligible for a booster infusion. The booster process consisted of 1 leukapheresis procedure followed by 1 infusion of sipuleucel-T. The booster process, in effect under protocol amendment 5, differed from the previous booster process that consisted of 1 infusion of the same treatment assigned at randomization (sipuleucel-T or control).

Subjects continued to be observed until DF was confirmed by bone scan or computed tomography (CT) scan, or other imaging modalities as clinically indicated. After confirmed DF, subjects were followed by telephone every 6 months for safety and survival, treatment-related AEs, any CVEs, or new therapies for prostate cancer.

PROvenge Treatment and Early Cancer Treatment

Autologous PAP-loaded Dendritic Cell Vaccine (Sipuleucel-T, APC8015, Provenge®) in Patients With Non-metastatic Prostate Cancer Who Experience PSA Elevation Following Radical Prostatectomy: a Randomized, Controlled, Double-blind Trial

Time to Biochemical Failure (TTBF) was the pre-specified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL

time to biochemical Failure (TTBF) was the pre-scpecified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL.

Dendreon

Provenge

Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF

Control

Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

ECOG 0=Fully Active; No restrictions.

ECOG 1= Restricted Strenuous Activity

ECOG Missing

ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about \>50% of waking hour; 3=Capable of limited self-care, confined to bed or chair \>50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead

Eastern Cooperative Oncology Group (ECOG) Performance Status

Weight

Gleason Score ≤ 6

Gleason Score =7

Gleason Score ≥ 8

Gleason score= prostate cancer grading system based on how tissue looks under a microscope. Scores range 2-10 and indicates how likely it is that a tumor will spread. A low score means the cancer tissue is similar to normal tissue and the tumor is less likely to spread. Gleason Score ≤ 6=the tumor is well differentiated, less aggressive and likely to grow more slowly;7=the tumor is moderately differentiated, moderately aggressive, and likely to grow but may not spread quickly;≥8=the tumor is poorly differentiated or undifferentiated, highly aggressive, and likely to grow faster and spread.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1	NCT03630809	Breast Cancer HER2-positive B... HER-2 Gene Ampl... HER2 Positive B... HER-2 Protein O... Breast Cancer, ... Breast Cancer F...	HER2 DC1 Vaccin...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance	NCT01687049	Prostate Cancer	Red yeast rice	19 Years - 90 Years	Sunnybrook Health Sciences Centre
PROvenge Treatment and Early Cancer Treatment	NCT00779402	Prostate Cancer	Control Sipuleucel-T	18 Years - 80 Years	Dendreon
Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance	NCT01687049	Prostate Cancer	Red yeast rice	19 Years - 90 Years	Sunnybrook Health Sciences Centre

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