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Immunomodulating Agents

Patients with cancer or a premalignant condition or at risk of cancer from an immunodeficiency

Scott M Norberg, D.O.

Background:

Cancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments.

Objective:

To better understand the biology of malignancies and why certain cancers respond differently to treatment.

Eligibility:

Adults at least 18 years old with cancer or a pre-cancerous condition.

Design:

Participants will be screened with a medical history, physical exam, and blood tests. Their diagnosis will be confirmed by the NCI Laboratory of Pathology.

Participants will send tissue blocks or slides from their original tumor biopsy.

At least once, participants will have a medical history, physical exam, and blood and urine tests.

Participants may have the following tests. They may have them more than once:

Apheresis. A needle in one arm removes blood. Blood is run through a machine and the sample cells are taken out. The rest of the blood is returned by a needle in the other arm.

Bone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle.

Piece of cancer tissue taken by a needle and syringe.

Computed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a machine that takes pictures.

A small piece of skin removed.

Participants will be contacted by phone once a year to find out how they are doing.

Background:

-Immunotherapy is a promising approach to the treatment of cancer. CIO investigators are studying immunotherapy for the treatment of diverse malignant and premalignant conditions. These studies require the collection of biospecimens for research purposes.

Objectives:

* To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with cancer or a premalignant disease or at risk of cancer from an immunodeficiency.
* To collect and bank biospecimens as directed by companion CIO immunotherapy clinical trial protocols.
* To conduct nucleic acid, protein, and immunological and biological research studies on samples collected.

Eligibility:

-Patients must be 18 years of age or older with a diagnosis of cancer or a premalignant condition or an immunodeficiency that increases the risk of being diagnosed with a cancer or premalignant condition.

Design:

* Up to 500 subjects will be enrolled.
* Patients will undergo sampling of blood, apheresis products, tumor, effusions, ascites, urine, bone marrow, serum, plasma, skin, mucosa, or other tissues for banking and laboratory studies.
* No investigational or experimental therapy will be given as part of this protocol.

Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols

.All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Biospecimen collection for study and understanding of disease.

Correlation of these characteristics with disease.

National Cancer Institute (NCI)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Prostatic Intraepithelial Neoplasia

Carcinoma

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Anticoagulants

Bone Density Conservation Agents

Antineoplastic Agents

Other Dietary Supplements

Citric Acid

Sodium Citrate

Toremifene

Antineoplastic Agents, Hormonal

Estrogens

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Hormones

Hormone Antagonists

Citrate

The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days).

The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days

Toremifene 20 mg

The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.

Placebo

Samir Taneja, MD

The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).

The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia. Men who have ever been diagnosed with high grade PIN will be enrolled into an 36 month trial and will be assigned to either 20 mg of study drug or placebo per day. Subjects will undergo safety evaluations at Month 3, Month 6, Month 12, Month 18, Month 24, Month 30 and Month 36 along with prostate biopsies at Month 12 and Month 24 and Month 36 to determine efficacy.

Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)

To measure the efficacy of toremifene citrate in men with high grade prostatic intraepithelial neoplasia (PIN). Prostate cancer-free survival distributions (Kaplan-Meier)

To measure the occurrence of a positive cancer biopsy

Measure lipid levels including total cholesterol, LDL, HDL and Triglycerides % change from baseline

% Change from baseline hormone levels, including total testosterone, free testosterone, dihydrotestosterone (DHT) and estradiol

To assess the effect of toremifene in the total PSA (prostate specific antigen) levels from baseline

To assess the effect of toremifene on the AUA (American Urological Association) symptom score mean change from baseline. Scores of 0-7=mild severity, 8-9, moderate, and 20-30, severe with possible responses of 0 (not at all) 1 (\<1/5), 2 (\<50% time), 3 (about 50% time), 4 (\> 50% time) \& 5 (Almost Always). There are 7 questions (1)Incomplete emptying (2)Frequency (3)Intermittency (4)Urgency (5)Weak-stream (6)Straining \& (7)Nocturia. Analysis is change from baseline at final evaluation (36 months) for quality of life due to urinary symptoms. The P Value is from a Wilcoxon signed-rank test. Scores can range from 0-35, highest representing worse symptoms

To measure the occurrence of high grade PIN at the 12, 24, 36 Month intervals in the 360 days study.

To assess the effect of toremifene in % free serum PSA (prostate specific antigen) levels, change from baseline

Toremifene 20mg

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Canada

Argentina

Region of Enrollment

Senior Director, Clinical Operations

MITT: Randomized subjects who were given study drug and did not return it unused and had a baseline and on-study prostate biopsy

Efficacy of Toremifene in the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)

Cholesterol

Triglycerides

All randomized subjects who take at least 1 dose of study drug

The Effect of Toremifene on Lipid Levels

Estradiol

Testosterone total

Testosterone free

Any randomized subject taking at least 1 dose of study drug

The Effect of Toremifene on Hormone Levels

The Effect of Toremifene on Total PSA (Prostate Specific Antigen) Levels

Reference to J Urol.1992 Nov;148(5):1549-57; discussion 1564. AUA symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Assocciation.

The Effect of Toremifene on the Mean Change at 36 Months in AUA (American Urological Association) Symptom Score

Determine occurrence of positive cancer biopsy

Determine occurrence of positive cancer biopsy and survival time

20 mg. Toremifene

Modified, intend-to-treat (MITT) all randomized subj. who take at least 1 dose of study drug, and had baseline and on-study prostate biopsies, where the baseline biopsy did not have cancer.

Occurrence of a Positive Cancer Biopsy

12 months

24 months

36 months

All randomized subjects that took 1 dose of study drug

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols	NCT02682667	Multiple Myelom... Lymphoma, Non-H... Leukemia-Lympho... Hodgkin Disease Non-Small Cell ...		18 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)	NCT00106691	Preneoplastic C... Prostatic Intra...	Toremifene 20 m... Placebo	30 Years -	GTx
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols	NCT02682667	Multiple Myelom... Lymphoma, Non-H... Leukemia-Lympho... Hodgkin Disease Non-Small Cell ...		18 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)	NCT00106691	Preneoplastic C... Prostatic Intra...	Toremifene 20 m... Placebo	30 Years -	GTx
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols	NCT02682667	Multiple Myelom... Lymphoma, Non-H... Leukemia-Lympho... Hodgkin Disease Non-Small Cell ...		18 Years - 120 Years	National Institutes of Health Clinical Center (CC)

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