Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Anti-Infective Agents

All Drugs and Chemicals

Herbal and Botanical

Niclosamide

Anthelmintics

Antiparasitic Agents

Cola

Niclosamide will be taken orally in the morning of each day from day 1-7 prior to surgery for resection of primary tumor. Niclosamide tablets must be chewed well prior to swallowing.

This study evaluates the safety of Niclosamide in patients with colon cancer that are undergoing primary resection of their tumor. This is a phase I study with three dosage levels to determine the maximum tolerated dose (MTD).

Niclosamide is a drug traditionally used in parasitic infections that has recently been shown to regulated the Wnt signaling pathway in cells at the level of the Frizzled receptor.

The Wnt pathway is critical for embryogenesis, differentiation of progenitor cells, and supports proliferation of neoplastic tissue. In cancer, activation of the Wnt pathway leads to increased transcription of genes important for growth, proliferation, differentiation, apoptosis, genetic stability, migration, and angiogenesis. The Wnt pathway has particular importance in colorectal cancer.

The purpose of this study is to obtain safety data along with pharmacokinetic data and information on the changes in the WNT pathway signalling following niclosamide administration in humans. This phase I study will support future studies in patients with more advanced cancer and other cancers with dysregulation of the Wnt pathway.

A Study of Niclosamide in Patients With Resectable Colon Cancer

A Phase I Study of Niclosamide in Patients With Resectable Colon Cancer

The NCI Common Toxicity Criteria version 4.0 will be used to grade adverse events to determine dose limiting toxicity for safety measure

he NCI Common Toxicity Criteria version 4.0 will be used to grade adverse events to determine dose limiting toxicity for safety measure

Michael Morse, MD

Professor

Blood and Lymph Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Niclosamide will be administered orally for 14 days. Each dose will be followed by backbone chemotherapy

Nancy Sweeters

Nancy Sweeters, RN, PNP

Kathleen Sakamoto, M.D., Ph.D

Adam Frymoyer, MD

Norman Lacayo, MD

Namrata Patel, PharmD

Jennifer Kamens, M.D

Kathleen M Sakamoto, MD, PhD

Protocol is designed to evaluate a niclosamide dose escalation scale in combination with cytarabine as a therapeutic modality for pediatric subjects with relapsed/refractory acute myeloid leukemia.

Niclosamide in Pediatric Patients With Relapsed and Refractory AML

Phase 1 Study of Niclosamide (ANA001) in Pediatric Patients With Relapsed and Refractory AML

Dose-limiting toxicities (DLTs) are defined as any events ≥ Grade 3 that are at least possibly, probably, or definitely related to niclosamide treatment

Clinical response is defined as any of the following.

* Complete response (CR) = \< 5% blasts in BM, with no evidence of extramedullary disease.
* Partial response (PR) = ≥ 5% to ≤ 25% blasts in BM with decrease in BM blast percentage by 50%, and no evidence of extramedullary disease.
* Resistant disease with clinical benefit (RD-CB) = either ≥ 5% to ≤ 25% blasts in BM OR a decrease in blast percentage by 50%, either with no evidence of extramedullary disease.

No response (NR) is defined as BM disease that does not fall into the above categories

Stanford University

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Carcinoma

Prostatic Neoplasms

Neoplasms, Glandular and Epithelial

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Anti-Inflammatory Agents

Hormones

Abiraterone Acetate

Prednisone

Cortisone

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Patients receive abiraterone acetate PO QD, niclosamide PO BID and prednisone PO BID. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Mamta Parikh

This phase II trial studies the side effects and how well abiraterone acetate, niclosamide, and prednisone work in treating patients with hormone-resistant prostate cancer. Androgens can cause the growth of prostate cells. Hormone therapy using abiraterone acetate may fight prostate cancer by lowering the amount of androgen the body makes. Niclosamide is a drug that may block another signal that can cause prostate cancer cell growth. Prednisone is a drug that can help lessen inflammation. Giving abiraterone acetate, niclosamide, and prednisone may be a better treatment for patients with hormone-resistant prostate cancer.

PRIMARY OBJECTIVES:

I. To determine the prostate-specific antigen (PSA) response that is a 50% or more reduction from the baseline.

SECONDARY OBJECTIVES:

I. To determine the overall response as determined by the Prostate Cancer Working Group 2 criteria (PCWG2).

II. To evaluate the progression-free survival (PFS) and overall survival of CRPC patients treated with PDMX1001/niclosamide (niclosamide), abiraterone (abiraterone acetate) and prednisone.

III. To assess the toxicity of PDMX1001/niclosamide, abiraterone and prednisone given in combination.

OUTLINE:

Patients receive abiraterone acetate orally (PO) once a day (QD), niclosamide PO twice a day (BID) and prednisone PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 3 months.

Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer

A Phase II Study With a Lead-in Safety Phase of Abiraterone in Combination With PDMX1001/Niclosamide in Castration-Resistant Prostate Cancer (CRPC)

Percent of patients achieving greater than or equal to 50% PSA declines following initiation of treatment

Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events 4.0. Adverse events and adverse events of grade 3 or higher will be listed for each patient and summarized by body system in a frequency table.

Will be estimated using the product-limit method of Kaplan and Meier; medians and 95% confidence intervals will be computed.

Will be estimated using the product-limit method of Kaplan and Meier; medians and 95% confidence intervals will be computed. Will be compared with the historic control of abiraterone alone.

National Cancer Institute (NCI)

Assistant Professor

Diseases and Abnormalities at or Before Birth

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Adenomatous Polyposis Coli

Nasopharyngeal Neoplasms

Rectal Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Polyps

Adenomatous Polyps

Adenoma

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

The subjects will be randomly assigned in a 2:1 ratio to receive niclosamide or identical-appearing placebo tablets orally for 6 months: niclosamide 650mg once a day in arm 1, placebo once a day in arm 2.

placebo

TAE IL KIM, Ph.D

Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and cardiovascular risks, and new preventive strategies are needed. Niclosamide, an anti-helminthic drug, has recently been suggested to have a suppressive effect on tumorigenesis via inhibition of Wnt pathway, and have no significant safety issues. The investigators devised a double-blind randomized controlled trial to evaluate the effect of niclosamide on polyps of colorectum and duodenum in FAP patients.

This clinical trial is a double-blind randomized controlled trial to evaluate the effect of niclosamide on polyps of colorectum and duodenum in FAP patients. FAP patients, satisfied an enrollment criteria, will be randomly assigned in a 2:1 ratio to receive niclosamide (650 mg) or placebo tablets orally once a day for 6 months. The base-line and six-month endoscopic examination (colonoscopy/sigmoidoscopy and upper gastrointestinal endoscopy) will be recorded, and photographs will be taken at the tattoo-marked area. The number and size of polyps, and a qualitative assessment of the total extent of polyposis will be measured. If there is no significant improvement in any of the 12 initial cases (niclosamide 8: placebo 4), this trial will be discontinued.

Niclosamide for Familial Adenomatous Polyposis

The Chemopreventive Effect of Niclosamide in Patients With Familial Adenomatous Polyposis: Double Blinded Randomized Controlled Study

At the base-line endoscopy (colonoscopy and upper gastrointestinal endoscopy), india-ink tattoo will be placed in the ascending colon, sigmoid colon/rectum, and duodenum. In case of the subjects with retained rectum after colectomy and ileorectal anastomosis, sigmoidoscopy will be performed. The base-line and six-month endoscopic examination will be recorded, and photographs will be taken at the tattoo-marked area and used for measurements of the number and size of polyps. The diameter of a polyp will be measured with the aid of biopsy forceps included in the photographic field, and only distinct polyps at least 2 mm in diameter will be counted.

A qualitative assessment of the total extent of colorectal polyposis will be conducted via video review(at base line and month 6) by two endoscopists experienced in the management of FAP, and scored as the same as, better than, or worse than base-line endoscopic findings, without the endoscopists' being aware of treatment group.

Yonsei University

Neoplasm Metastasis

Patients receive 2 g niclosamide orally per day until progression or toxicity

Susen Burock

Phase II trial evaluating the safety and efficacy of oral appliqued niclosamide in patients who are progressive with metachronous or synchronous metastases of colorectal cancer among the previous therapy (Nikolo). Monocentric open-label clinical trial of phase II. All patients received 2 g p.o. niclosamide daily until progression (according to RECIST) or unacceptable toxicity or discontinuation of study for other reasons.

Effectiveness:

• effectiveness is measured by progression-free survival evaluated by RECIST (Response Evaluation Criteria In Solid tumor).

Overall survival For overall survival, the curves are estimated using the Kaplan-Meier method

Drug Trial to Investigate the Safety and Efficacy of Niclosamide Tablets in Patients With Metastases of a Colorectal Cancer Progressing After Therapy

Phase II Trial to Investigate the Safety and Efficacy of Orally Applied Niclosamide in Patients With Metachronous or Synchronous Metastases of a Colorectal Cancer Progressing After Therapy

defined as the time from patient inclusion to the date of progression

defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)

remission + partial remission + stable disease

number of adverse events \> grade 2 toxicities according to NCI Common Toxicity Criteria for Adverse Effects v 4.03

Center for Molecular Medicine

Charite University, Berlin, Germany

Patients receive niclosamide PO BID and enzalutamide PO QD on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Enzalutamide

This phase I trial studies the best dose and side effects of niclosamide when given together with enzalutamide in treating patients with castration-resistant prostate cancer that has come back or has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of androgen by the tumor cells. Niclosamide may block signals that enhance prostate cancer cell growth. Giving enzalutamide and niclosamide may work better in treating patients with castration-resistant prostate cancer.

PRIMARY OBJECTIVES:

I. To determine the safety of niclosamide (PDMX1001/niclosamide) and enzalutamide in patients with castration-resistant prostate cancer (CRPC).

II. To determine the recommended phase II dose (RP2D) of PDMX1001/niclosamide and enzalutamide for the treatment of patients with CRPC.

SECONDARY OBJECTIVES:

I. To determine the pharmacokinetics of PDMX1001/niclosamide. II. To determine the number of patients who have a prostate-specific antigen (PSA) response that is a 50% or more reduction from the baseline.

III. To identify overall responses as determined by the Prostate Cancer Working Group 2 (PCWG2) criteria.

IV. To evaluate the progression-free survival (PFS) of CRPC patients treated with PDMX1001/niclosamide and enzalutamide.

V. To evaluate molecular correlatives for patient response and outcomes through the analysis of patient baseline tumor specimens (diagnostic biopsy) along with serial blood specimens.

OUTLINE: This is a dose-escalation study of niclosamide.

Patients receive niclosamide orally (PO) twice daily (BID) and enzalutamide PO once daily (QD) on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 3 months.

Enzalutamide and Niclosamide in Treating Patients With Recurrent or Metastatic Castration-Resistant Prostate Cancer

A Safety Trial of Enzalutamide in Combination With PDMX1001/Niclosamide in Castration-Resistant Prostate Cancer (CRPC)

Will be performed between patients who respond and those who do not respond, and between specimens obtained during response and those specimens obtained during resistance in the same patients. Will be descriptive and exploratory.

Adverse events and adverse events of grade 3 or higher will be listed for each patient and summarized by body system in a frequency table.

Determination of dose limiting toxicity as graded according to NCI CTCAE 4.0.

The characteristics of the study participants will be summarized using frequencies and percentages for categorical variables and descriptive statistics (mean, standard deviation, median, minimum, maximum) for numeric variables. The proportion of participants who experience a PSA response will be computed, along with the exact 95% confidence interval.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Niclosamide in Patients With Resectable Colon Cancer	NCT02687009	Colon Cancer	Niclosamide	18 Years - 99 Years	Duke University
Niclosamide in Pediatric Patients With Relapsed and Refractory AML	NCT05188170	Acute Myeloid L...	Niclosamide	2 Years - 25 Years	Stanford University
Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer	NCT02807805	Metastatic Pros... Recurrent Prost... Stage IV Prosta...	Abiraterone Ace... Niclosamide Prednisone	19 Years -	University of California, Davis
Niclosamide in Pediatric Patients With Relapsed and Refractory AML	NCT05188170	Acute Myeloid L...	Niclosamide	2 Years - 25 Years	Stanford University
Niclosamide for Familial Adenomatous Polyposis	NCT04296851	Familial Adenom...	Niclosamide placebo	20 Years - 65 Years	Yonsei University
Niclosamide in Pediatric Patients With Relapsed and Refractory AML	NCT05188170	Acute Myeloid L...	Niclosamide	2 Years - 25 Years	Stanford University
Drug Trial to Investigate the Safety and Efficacy of Niclosamide Tablets in Patients With Metastases of a Colorectal Cancer Progressing After Therapy	NCT02519582	Colorectal Canc...	Niclosamide	18 Years -	Charite University, Berlin, Germany
Enzalutamide and Niclosamide in Treating Patients With Recurrent or Metastatic Castration-Resistant Prostate Cancer	NCT03123978	Metastatic Pros... Recurrent Prost... Stage IV Prosta...	Enzalutamide Niclosamide	19 Years -	University of California, Davis

Spots Global Cancer Trial Database for niclosamide

Every month we try and update this database with for niclosamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for niclosamide

Every month we try and update this database with for niclosamide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for niclosamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.