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Soy Bean

This is a prospective cohort study of 96,000 members of the Seventh-day Adventists Church in the United States and Canada age 30 and older at the time of enrollment who are proficient in English language.

Gary E Fraser, MD,PhD

The Adventist Health Study-2 is a long-term study, exploring the links between lifestyle, diet, and disease outcomes among Seventh-day Adventists. More than 96,000 church members from the U.S. and Canada are participating in the current study, AHS-2, conducted by researchers at the Loma Linda University School of Public Health.

The Adventist Health Study-2 (AHS-2) is a large national cohort of 96,000 Seventh-day Adventists in the U.S. and Canada. The study is searching for associations between diet and risk of common and medium frequency cancers (breast, prostate, colorectal, lung, uterus, pancreas, melanoma of skin). This cohort is unusual in that about half are vegetarian, many eat soy at Asian levels, and many have very low or absent dairy intake while others eat normal amounts of dairy. Thus observations on these people, many of whom have contrasting dietary habits, may provide insights about diet and cancer, so supporting dietary changes that could be readily adopted by many.

Buffy coat samples from a sample of the cohort (\~2500) are stored from which DNA material may be extracted when a study requires such data. Other stored bio-specimens from a sample of the cohort include adipose tissue, urine, blood, sputum, stool.

Plant-based Diets and Risk of Cancer in the Adventist Health Study-2

Cancer Epidemiology in Seventh-day Adventists

Researchers must write a proposal describing how the data will be used and submit it to the Adventist Health Study data sharing committee for approval.

Incident cases of colorectal cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes.

Incident cases of breast cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes.

Incident cases of prostate cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes.

National Cancer Institute (NCI)

World Cancer Research Fund International

Ardmore Institute of Health

Loma Linda University

Antineoplastic Agents

Analgesics

Anti-Inflammatory Agents

Antibodies

Antibodies, Monoclonal

Mitoxantrone

Hormones

Prednisone

Immunoglobulins

Siltuximab

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

In Part 1, mitoxantrone 12 milligram per square meter (mg/m\^2) will be given intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2) along with siltuximab 6 mg/kilogram (mg/kg) intravenously as a 2 hour-infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.

In Part 2, mitoxantrone 12 mg/m\^2 will be given intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.

In Part 2, mitoxantrone 12 mg/m\^2 will be given intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.

Mitoxantrone 12 mg/m\^2 intravenously as a 30 minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2)

Siltuximab 6 mg/kg intravenously as a 2 hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year

Centocor, Inc. Clinical Trial

The purpose of this study is to assess the safety and efficacy of siltuximab administered in combination with mitoxantrone and prednisone in participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (abnormal tissue that grows and spreads in the body) (HRPC).

This is a 2-part, open-label (all people know the identity of the intervention) multicenter (when more than 1 hospital or medical school team work on a medical research study), Phase 2 study to evaluate the safety and efficacy of the combination of siltuximab plus mitoxantrone versus mitoxantrone in participants with metastatic HRPC who have received 1 prior Docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical agents) regimen (pattern of giving treatment). Part 1 of the study is single arm where participants will receive mitoxantrone, prednisone and siltuximab. Part 2 of the study is randomized portion (the study drug is assigned by chance), consisting of 2-arms. The experimental arm will consist of treatment with mitoxantrone, prednisone and siltuximab. The control arm will consist of treatment with mitoxantrone and prednisone. Mitoxantrone will be administered at a dose of 12 milligram per square meter (mg/m\^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle, until disease progression or unacceptable toxicity (any harmful effect of a drug) or up to 10 cycles (a maximum total dose of approximately 120 mg/m\^2). Siltuximab will be administered at a dose of 6 mg/kilogram intravenously as a 2-hour infusion, starting Day 1 of Cycle 1 to continue every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year. All participants will receive prednisone 5 mg twice daily starting with the first administration of Mitoxantrone. The duration of treatment will be a maximum of 12 months for cumulative dose. Radiologic assessments will be performed on Week 12 after the first study agent dosing, then every 9 weeks until the end of treatment and then once every 3 months until documented disease progression. Tumor (a mass in a specific area) response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. There will be short-term follow-up visits (conducted monthly for 2 months), followed by long-term follow-up visits (conducted once every 3 months). Participants' safety will also be monitored throughout the study.

A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)

A Phase 2, Multicenter, Open-Label Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) in Combination With Mitoxantrone Versus Mitoxantrone in Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

The PFS is the time from the date of randomization until the first documented sign of progression (at least a 20 percent increase in the sum of the longest diameter \[LD\] of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new target or non-target lesions as per Response Evaluation Criteria in Solid Tumors \[RECIST\] or 3 or more new skeletal lesions on bone scan with confirmation of second bone scan or with clinical deterioration) or death, whichever occurs first.

The TtCD is defined as the time from the start of treatment (for participants in Part 1) or randomization (for participants in Part 2) until the first documented clinical deterioration (consists of pain requiring palliative (intended to relieve pain) intervention (a treatment given during the course of a research study), or death due to any cause, whichever occurs earlier.

Palliative response was defined as a 2-point or greater reduction from baseline pain, without a categorical increase in prescribed disease-related analgesic (drug used to control pain) use or at least a categorical decrease in disease-related analgesic use without a concomitant (given at the same time) increase in pain. Each component required confirmation at least 3 weeks later.

The PSA response is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value at least 3 weeks after initial documentation of PSA response.

The OS is defined as the time from the date of start of treatment (for participants in Part 1) or randomization (for participants in Part 2) to death due to any cause. For participants who were alive at the time of analysis, OS was censored at the last contact date.

Centocor, Inc.

Safety population in Part 1 and 2 included all participants who received at least one dose of study drug.

Participants received mitoxantrone 12 milligram per square meter (mg/m\^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.

Part 1: Mitoxantrone + Prednisone + Siltuximab

Participants received mitoxantrone 12 mg/m\^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.

Part 2: Mitoxantrone + Prednisone

Participants received mitoxantrone 12 mg/m\^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.

Part 2: Mitoxantrone + Prednisone + Siltuximab

Total

Age, Continuous

Sex: Female, Male

AUSTRIA

BELGIUM

FRANCE

GERMANY

SPAIN

UNITED KINGDOM

UNITED STATES

Region of Enrollment

Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.

Results of few secondary endpoints were not reported as the study was terminated early due to the premature suspension and subsequent halting of study enrollment.

Director

SAEs

Safety population in Part 1 included all participants who received at least one dose of study drug.

Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Intent-to-treat (ITT) population in Part 2 included all randomized participants.

Part 2: Progression Free Survival (PFS)

Time to Clinical Deterioration (TtCD)

Data for this outcome measure was not analyzed because minimal efficacy analysis (primary and key secondary endpoints) was done due to early termination of study.

Number of Participants With Palliative Response

Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Plant-based Diets and Risk of Cancer in the Adventist Health Study-2	NCT03615599	Cancer, Breast Cancer, Colorec... Cancer, Prostat...		30 Years -	Loma Linda University
A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)	NCT00385827	Cancer, Prostat...	Mitoxantrone Siltuximab Prednisone	18 Years -	Centocor, Inc.
Plant-based Diets and Risk of Cancer in the Adventist Health Study-2	NCT03615599	Cancer, Breast Cancer, Colorec... Cancer, Prostat...		30 Years -	Loma Linda University

Spots Global Cancer Trial Database for cancer, prostate