Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Dexamethasone

Colchicine

Lenalidomide

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Tubulin Modulators

Antimitotic Agents

Patients will be treated with colchicine, lenalidomide and dexamethasone, every 28 days as a cycle.

Patients will receive lenalidomide and dexamethasone as background treatment, every 28 days as a cycle.

The investigational drug colchicine was used at a daily dose of 0.5-1 mg. In every cycle, lenalidomide was administered at 10-25 mg (days 1-21). Dexamethasone 40mg (≤75 years old) or 20mg (\>75 years old) per week.If the weekly dose of dexamethasone is 40mg, it should be taken in the first two days of the week, 20mg per day; If the weekly dose is 20mg or take the lower dose on the first day of each week.

If the patient needs to be treated with the investigational drug colchicine on the day of dexamethasone administration, he should take dexamethasone orally within 3 hours before the administration of colchicine.

In every cycle, lenalidomide was administered at 10-25 mg (days 1-21). Dexamethasone 40mg (≤75 years old) or 20mg (\>75 years old) per week.If the weekly dose of dexamethasone is 40mg, it should be taken in the first two days of the week, 20mg per day; If the weekly dose is 20mg or take the lower dose on the first day of each week.

Hongming Huang, PhD

To evaluate the efficacy and safety of investigational drug Colchicine combined with conventional lenalidomide based therapy in multiple myeloma subjects who had received first-line therapy (including Chimeric antigen receptor T-Cell immunotherapy (CART) treatment), and to evaluate the quality of life of the patients.

This study is expected to be carried out from March 2022 to December 2024. About 30 patients with multiple myeloma who have received at least first-line of treatment (including Chimeric antigen receptor T-Cell immunotherapy (CART) treatment) will be randomly assigned to the experimental group or the control group at 2:1. By comparing the relevant data such as efficacy evaluation and safety evaluation after treatment, the principal investigator will write and publish the paper.

The Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients

A Single-center Clinical Trial to Evaluate the Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients

Changes of the level of Serum M protein before and after treatment

Changes of the proportion of bone marrow plasma cells before and after treatment

Changes of the level of SPEP and UPEP before and after treatment

Changes of the level of Serum FLC before and after treatment

Changes of the level of CBC before and after treatment

Changes of the ECOG score before and after treatment.

Affiliated Hospital of Nantong University

Deputy Director of Hematology Department

Symptoms and General Pathology

Inflammation

Participants with advanced/recurrent solid tumors who will receive low-dose colchicine (0.6 mg oral BID)

Participants with metastatic solid tumors who will receive high-dose colchicine (0.6 mg oral TID)

Participants with post-radical surgery for high-risk clinically localized urothelial cancer will receive colchicine 0.6 mg oral BID.

Patients will receive 14 days of colchicine in the absence of prohibitive toxicity of disease progression

Natalie Lucas

Deborah B Doroshow, MD, PhD

Deborah Doroshow

This open-label, non-randomized study aims to determine the anti-inflammatory effect of colchicine on the reduction of peripheral blood CRP in patients with solid tumors or localized urothelial cancer. There are two cohorts, which will enroll separately and parallelly. Cohort 1 will include two successive groups with advanced/recurrent solid tumors (15 patients will receive low-dose colchicine and 15 for high-dose colchicine) who will receive 14 days of colchicine. In Cohort 2, 15 patients with post-radical surgery for high-risk clinically localized urothelial cancer will be enrolled. They will receive one 28-day cycle of colchicine. The primary outcome, post-treatment decline in CRP level, a continuous measure, will be defined as the maximum percentage decline from baseline in post-treatment CRP value within two weeks of colchicine (Cohort 1) or one cycle of colchicine (cohort 2), where the baseline value is measured before any treatment is initiated.

Pilot Trial of Colchicine in Urothelial Cancer and Other Solid Tumors

Colchicine to Suppress Pro-tumorigenic Inflammation in Patients With Urothelial Cancer and Other Solid Tumors

Data will not be shared due to the small cohort size.

The primary outcome, post-treatment decline in peripheral blood CRP level, a continuous measure, will be defined as the maximum percent decline of post-treatment CRP from baseline obtained during the treatment period, where the baseline value is measured before any treatment initiated For a patient with an advanced/recurrent solid tumor who receive 2-weeks of treatment, it will be the maximum percentage decline during the 28 days of treatment. For a patient who receive colchicine less than 28 days, it will be the maximum percentage decline from baseline to the last day of treatment.

Icahn School of Medicine at Mount Sinai

Assistant Professor

Digestive System Diseases

Carcinoma

Neoplasm Metastasis

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplastic Processes

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

2 tablets (0.5 mg/tablet) of colchicine three times per day (after breakfast, lunch and dinner); continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial

Adjustment the dosage of colchicine during study:

The colchicine dosage will be changed when the hepatic reserved function of the participant changes from Child A to B according as following: 2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner; continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial. If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.If participant suffers from severe diarrhea, colchicine will be temporarily stopped. When the symptom of diarrhea subsides, colchicine will be given again but the dose will be reduced 0.5 mg/day.

Zu Y Lin, MS

This trial is to evaluate the potential of colchicine for the palliative management of hepatocellular carcinoma patients with distant metastasis or large vessel invasion using the Department of Health R.O.C. approved doses and methods of administration.

Dosing schedule: 2 tablets (1 mg) three times per day (after breakfast, lunch and dinner); continue 4 days and stop for 3 days (1 cycle)

Adjustment the dosage of colchicine during study:

1. The colchicine dosage will be changed when the hepatic reserved function of the participant changes from Child A to B according to the following rules.

   1. 2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner; continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial
   2. If the hepatic reserved function of the participant returns to Child A, The dosage for Child A will be restored.
   3. If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.
2. If participant suffers from severe diarrhea, colchicine will be temporarily stopped. When the symptom of diarrhea subsides, colchicine will be given again according to the following rules.

   1. For participant receives﹝2 tablets after breakfast, 2 tablet after lunch and 2 tablets after dinner﹞, the dosage of colchicine will be changes to﹝2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner﹞.

      If diarrhea attacks again, the dosage of colchicine will be changes to﹝2 tablets after breakfast and 2 tablets after dinner﹞.

      If diarrhea attacks again, the dosage of colchicine will be changes to﹝2 tablets after breakfast, 1 tablet after dinner﹞.

      If diarrhea also attacks again, colchicine will be stopped and participant receives regular follow-up only.
   2. For participant receives﹝2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner﹞, the dosage of colchicine will be changes to﹝2 tablets after breakfast and 2 tablets after dinner﹞.

   If diarrhea attacks again, the dosage of colchicine will be changes to﹝2 tablets after breakfast, 1 tablet after dinner﹞.

   If diarrhea also attacks again, colchicine will be stopped and participant receives regular follow-up only.
3. If the participant has one of the following conditions, colchicine will be temporarily stopped. When the condition of the participant improves, colchicine will be given again after the judgment from the doctor of the research team. For participants unable to receive colchicine again, they will receive regular follow-up only.

   1. There are life-threatening hemorrhage including gastrointestinal hemorrhage and hemorrhage from other vital organs such as lungs or brain.
   2. . There are life-threatening bacterial, fungal or viral infection (not included hepatitis B and C virus).
   3. . Patient has serum creatinine level \> 1.5 mg/dL.
   4. . Patient has white blood cell count \< 1500/µL, platelet count \< 30000/µL or hemoglobin \< 9.0 gm/dL after medication.
   5. The research team decides that the participant is not suitable to continue the study caused by abnormality of any vital organ or severe side effects caused by the study.
4. Colchicine will be temporarily stopped one day before transcatheter arterial chemoembolization until participant has body temperature \< 38 ℃, same hepatic reserved function as before, and serum creatinine level \< 1.5 mg/d after embolization.

Follow-up procedures and items for the participants to co-operate:

All participants will be followed according to the guide line of the National Health Council and the clinical practice in the treatment of hepatocellular carcinoma. Contrasted-enhanced computed tomography or magnetic resonance imaging will be performed within every 3 to 4 months. Serum alpha-fetoprotein will be determined at least one session within every 2 to 3 months in patients with elevated serum alpha-fetoprotein levels. The hepatic and renal function will be determined at least one session every month. The participants are asked to visit our outpatient clinic at least one session every month.

Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma

Evaluation the Potential of Colchicine for the Palliative Management of Hepatocellular Carcinoma Patients With Distant Metastasis or Large Vessel Invasion

The overall survival of the participants calculated from the date of enrollment to the date of death will be compared with the control group with the same TNM and the Barcelona Clinic Liver Cancer (BCLC) staging collected from 2005/1/1 to the end of this study. The overall survival of the control group was calculated from the date of receiving sorafenib treatment to the date of death.

The type and frequency of grade III severe adverse events based on the Common Terminology Criteria for Adverse Events (CTCAE) noted during the study period.

Kaohsiung Medical University Chung-Ho Memorial Hospital

professor

The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.

2 tablets (0.5 mg/tablet) of colchicine three times per day (after breakfast, lunch and dinner); continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial

Colchicine: Adjustment the dosage of colchicine during study:

The colchicine dosage will be changed when the hepatic reserved function of the participant changes from Child A to B according as following: 2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner; continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial. If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.If participant suffers from severe diarrhea, colchicine will be temporarily stopped. When the symptom of diarrhea subsides, colchicine will be given again but the dose will be reduced 0.5 mg/day.

Colchicine Group

The control group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.

Sorafenib Treated Group

This group included participants receiving total daily colchicine dose equal or larger than 1.5 mg for more than 8 cycles (28 days).

Colchicine Treated Patients

This group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Taiwan

open labeled phase II for AJCC TNM IIIB to IVB hepatocellular carcinoma patient

Region of Enrollment

The participant received more than 8 courses of colchicine management.

Dr. Zu-Yau Lin

Participant received more than 8 courses of colchicine management.

Overall Survival

Comparison the incidence of grade III adverse event of pneumonia between two groups

Comparison the incidence of grade III adverse event of biliary tract obstruction between two groups

Comparison the incidence of grade III adverse event of cholangitis between two groups

Comparison the incidence of grade III adverse event of peritonitis between two groups

Comparison the incidence of grade III adverse event of sepsis between two groups

Comparison the incidence of grade III adverse event of diarrhea between two groups

Comparison the incidence of grade III adverse event of anorexia between two groups

Comparison the incidence of grade III adverse event of abdominal pain between two groups

Comparison the incidence of grade III adverse event of skin rash between two groups

Comparison the incidence of grade III adverse event of palmar-plantar erythrodysesthesia syndrome between two groups

Comparison the incidence of grade III adverse event of hypertension between two groups

Comparison the incidence of grade III adverse event of hemorrhage between two groups

Comparison the incidence of grade III adverse event of hypoglycemia between two groups

Comparison the incidence of grade III adverse event of hyperglycemia between two groups

Comparison the incidence of grade III adverse event of hypocalcemia between two groups

Comparison the incidence of grade III adverse event of pleural effusion between two groups

Diarrhea

Anorexia

Biliary tract obstruction

Abdominal pain

Hypoglycemia

Pneumonia

Peritonitis

Cholangitis

Sepsis

Skin rash

Palmar-plantar erythrodysesthesia syndrome

Hypertension

Hemorrhage

Hyperglycemia

Hypocalcemia

Pleural effusion

This included the events occured after the participant signed the inform consent.

Grade III Severe Adverse Events

The dosing schedule started from 1 mg three times per day after meal for 4 days and stopped for the following 3 days (1 cycle). This cycle was repeated till the participant quitted this trial.

Adjustment of colchicine dosage during study:

1. The colchicine dosage was changed when the hepatic reserved function of the participant changed from Child A to B or C according to the following rules.

   1. Total daily dose reduced to 2.5 mg (1mg morning, 0.5 mg afternoon, 1 mg night) for participant with Child class B.
   2. If the participant changed to Child class C, colchicine will be stopped and participant received regular follow-up only.
2. Colchicine was temporarily stopped in participant suffered from diarrhea and was started again with reducing daily total dose of 0.5 mg.
3. Colchicine was temporarily stopped when the participant fitted any of the exclusion criteria during the study, and was given again after the fitted exclusion criterion was eliminated.

Overall Study

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

Docetaxel

Colchicine 0.6 mg bid to a maximum of 1.2 mg bid

Joseph J Drabick, MD

The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine.

The investigators propose a simple phase II trial of oral colchicine at the standard prophylactic dose utilized for gout in men with CRPCa who have failed taxotere based chemotherapy. The investigators will utilize a simple modified Simon 2-stage design. The investigators plan to enroll 40 men for the study. The men should have completed prior taxotere based therapy or any other therapy post-taxotere including cabazitaxel one month prior to receipt of colchicine on trial. Staging with a baseline bone scan, CT and PSA as well as routine CBC, CMP and PAP. The dose of the drug can be escalated as tolerated to a maximum of 1.2 mg bid. The patient would be seen at 21 day intervals. After every 3 cycles of treatment, patient would be restaged with CT and bone scan. Patients with stable disease, partial response or complete response would continue therapy until either disease progression or intolerable toxicity after which the patient would be taken off study.

Oral Colchicine in Men With Castrate Resistant Prostate Cancer

Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy

Determine the PSA response rate to continuous low dose oral colchicine

Determine the safety and tolerability of continuous low dose oral colchicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients	NCT05802992	Multiple Myelom...	Colchicine Lenalidomide	18 Years - 80 Years	Affiliated Hospital of Nantong University
Pilot Trial of Colchicine in Urothelial Cancer and Other Solid Tumors	NCT05279690	Urothelial Canc... Metastatic Soli...	Colchicine	18 Years -	Icahn School of Medicine at Mount Sinai
Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma	NCT01935700	Hepatocellular ... Metastasis Invasion	Colchicine	20 Years - 90 Years	Kaohsiung Medical University Chung-Ho Memorial Hospital
Oral Colchicine in Men With Castrate Resistant Prostate Cancer	NCT01481233	Prostate Cancer	Colchicine	18 Years -	Milton S. Hershey Medical Center
Oral Colchicine in Men With Castrate Resistant Prostate Cancer	NCT01481233	Prostate Cancer	Colchicine	18 Years -	Milton S. Hershey Medical Center
The Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients	NCT05802992	Multiple Myelom...	Colchicine Lenalidomide	18 Years - 80 Years	Affiliated Hospital of Nantong University

Spots Global Cancer Trial Database for colchicine

Every month we try and update this database with for colchicine 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 colchicine

Every month we try and update this database with for colchicine 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 colchicine 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.