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

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Antineoplastic Agents

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All Drugs and Chemicals

Anti-Infective Agents

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Analgesics

Cyclophosphamide

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Bortezomib

Chloroquine

Chloroquine diphosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Amebicides

Antiprotozoal Agents

Antiparasitic Agents

Antimalarials

VELCADE given by intravenous push at 1.3 mg/m\^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.

Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.

Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.

Each cycle is 42 days in length.

Velcade

Michael Grossbard, MD

This pilot phase II trial studies how well giving bortezomib and cyclophosphamide together with chloroquine works in treating patients with relapsed or refractory multiple myeloma.

Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chloroquine may help chemotherapy drugs work better by making cancer cells more sensitive to the drug. Giving bortezomib and cyclophosphamide together with chloroquine may kill more cancer cells.

Chloroquine in Combination With VELCADE and Cyclophosphamide for Relapsed and Refractory Multiple Myeloma

A Phase II, Trial of Chloroquine in Combination With VELCADE and Cyclophosphamide in Patients With Relapsed and Refractory Myeloma

Response rate is defined as the percentage of patients who have a complete response (CR) or partial response (PR). Responses were assessed every two cycles of treatment, based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006). Per International Myeloma Working Group response criteria:

CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow PR: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h

Adverse events reported here were at least possibly related to the protocol therapy.

Duration of response is the time from response (CR or PR) until progression of disease or relapse. Responses and progression were evaluated based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006).

Millennium Pharmaceuticals, Inc.

NYU Langone Health

All adverse events were reported regardless of attribution to protocol therapy.

Velcade+Cyclophosphamide+Chloroquine

45-53 years

54-63 years

64-73 years

74-83 years

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Amitabha Mazumder, MD

Response Rate (CR + PR After 2 Cycles)

Fatigue

Hemoglobin

Nasal cavity/paranasal reactions

ANC/AGC

Pain: pleural

Platelets

Number of Participants With Adverse Events of Grade 3 or Higher

Study was terminated prior to collection of this data point.

Percentage of Subjects Who Have Complete Response or Partial Response and Have 2+ or Higher Autophagy

Median Duration of Response of This Regimen

Overall Study

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Julio Sotelo, MD

Chloroquine is a strong lysosomotropic and DNA-intercalating agent in experimental studies (Neurosurgical Focus 14(2): February, 2003) and an open-label clinical trial the investigators have demonstrated a strong adjuvant effect of chloroquine on the therapy of malignant gliomas. This study will assess in a randomized, placebo-controlled, double-blind study the effects of chloroquine as adjuvant to the conventional therapy of Glioblastoma Multiforme.

ANTECEDENTS: We have shown experimentally a significant adjuvant effect of quinacrine (an analog of chloroquine) on cultured malignant glial cells and C6 implanted malignant glioma in Wistar rats. When quinacrine was added to the standard therapy with carmustine cell destruction and tumor diminution were higher than therapy with carmustine alone. Those results were published in Neurosurgery 2001; 49:969-973 (at that time the manuscript was "in press").

The present protocol started with a controlled, open-label clinical trial on 7 patients with GBM and 7 contemporary control patients. All patients received the same treatment of extensive surgery, carmustine therapy and irradiation at the standard doses as (as described in our previous report Surgical Neurology 2000; 53:157-162). Once selected to enter the study the patients were allocated alternatively in the chloroquine or the control group. Endpoint evaluation was settled as surviving time after the beginning of therapy and the end point follow-up was settled in survivors at two years after the beginning of treatment.

18 months after the beginning of the open trial it was observed that chloroquine treated patients had a longer survival and no adverse effects to chloroquine therapy were seen.

At that time it was decided to start the second part of the protocol designed as a double-blind placebo-controlled trial, ideal number of patients to be included was settled in 15 patients on each group.

The results of the 1st. phase of the study by the open-label trial were published in Neurosurgical Focus (http://www.aans.org/education/journal/neurosurgical/feb03/14-2-3.pdf) on February, 2003.

In order to corroborate the observations (at that time with a short follow-up) of the open trial the double-blind, a placebo-controlled study was initiated in October, 2000; the dose of chloroquine for the blind study was decided to be maintained in 150 mg daily for one year after the beginning of therapy.

The Research Committee was notified on the beginning and the design of this trial: 6,000 tablets of chloroquine 150 mg (Aralen) and 6,000 identical tablets of placebo were commercially purchased and sent to the laboratory of Dr. Roberto Medina at the National Polytechnic Institute (selected as monitor). 30 sets of 375 tablets each were separated (15 contained chloroquine and 15 placebo) in identical flasks, the assignment of treatments was randomly allocated; the codified treatments numbered 1-30 were then sent back to our Institute. The code was sealed and kept by the monitor until the end of the study. Patients included in the study were given the corresponding treatment in sequential order.

Criteria for inclusion of patients in the trial is detailed in methods of the manuscript submitted to the Annals of Internal Medicine Ms. # M0-1087 (pages 6-7).

Follow-up and statistical analysis: End-point evaluation was settled as time of death after the beginning of therapy. Follow-up for survivors was settled at 2 years after the beginning of treatment. Survival distributions were analyzed as a Kaplan-Meier plot and compared by the log rank test. Statistical analysis of demographic, clinical and imaging characteristics of patients was made by the t test for independent values.

After more than four years from the beginning of the study 26 patients from the originally decided goal number of 30 patients had completed at least two years of follow-up. At this time (January 2005) it was decided to open the code and proceed with the analysis of those patients, which turned out to be 13 chloroquine-treated and 13 placebo-treated patients. The last 4 patients (who were not included in the analysis) are currently under treatment but their follow-up will end next year (2 patients are received chloroquine and the other 2 placebo).

No patient initially selected refuse to enter the study, nor any patient included was lost at follow-up. All 26 patients included in the study have been followed until the time of death or up to July 2005 in survivors.

Chloroquine for Treatment of Glioblastoma Multiforme

Chloroquine as Adjuvant to the Treatment of Glioblastoma Multiforme, A Randomized Trial

National Institute of Neurology and Neurosurgery, Mexico

Symptoms and General Pathology

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the CLQ plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days.

30 Gy of whole-brain radiotherapy in 10 daily fractions and an oral matching placebo for 28 days

The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the Chloroquine plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days

30 Gy in 10 daily fractions from Monday to Friday

Total brain radiotherapy

Oscar Arrieta, MD

Background and purposes:Chloroquine (CLQ), an antimalarial drug, has a lysosomatrophic effect associate with increase the sensibility of Radiation through leakage of hidroliticenzimes, increase of apoptosis, autophagy mediated by lysosomalhidrolases and increase of oxidative stress "in vitro". In this phase II study we evaluated the efficacy and safety as radiosensitizing of the Chloroquine plus concomitant 30 Gray (Gy) of Whole-brain irradiation (WBI)in patients with brain metastases (BM) from solid tumors.

Seventy-three eligible patients were randomized. Thirty-nine patients received WBI (30 Gy in 10 fractions over 2 weeks) concomitant with 150 mg of CLQ for 4 weeks (the CLQ group). Thirty-four patients received the same schedule of WBI concomitant with a placebo for 4 weeks (the control arm). All the patients were evaluated for quality of life (QoL) using the EORTC QLQ-C30 questionnaire (Mexican version) before beginning radiotherapy and one month later.

Study of Whole-brain Irradiation With Chloroquine for Brain Metastases

Phase II Randomized, Double Blind, Placebo Controlled Study of Whole-brain Irradiation With Concomitant Daily-dose Chloroquine for Brain Metastases.

The 30-item EORTC Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) version 3.0 (Mexican version) was used in this trial. The EORTC QLQ-C30 v3 consisted of five multi-item functional scales, three symptom scales, a global health status/QoL scale, and six single items

Corresponding Complete plus Partial Response according with RECIST 1.1 Criteria

Clinical o radiological brain progression or death. Radiological Progression is measured by RECIST 1.1 Criteria

Instituto Nacional de Cancerologia de Mexico

Principal Investigator

Gemcitabine

Carboplatin

Antimetabolites

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Anthelmintics

Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating.

Dose is 50, 100, 150, and 200 mg per day cohorts. It is given one week prior to the initiation of chemotherapy and then given for four 21 day cycles in combination with chemotherapy.

Administered day 1 of each 21 day cycle for 4-6 cycles.

Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.

Nagla Abdel-Karim, MD

The purpose of this research study is to test the safety of chloroquine in combination with carboplatin and gemcitabine and see what effects (good and bad) it has on advanced solid tumors.

Also, the research study will be increasing the dose of chloroquine to find the highest dose of chloroquine that can be given in combination with carboplatin and gemcitabine without causing severe side effects.

Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

A Phase 1 Study of Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

University of Cincinnati

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Daily intake of Chloroquine during radiotherapy

Philippe Lambin, MD, PhD

Chloroquine can make tumor cells less resistant to chemo/radiotherapy. In this trial chloroquine is given during radiotherapy. The dose is increased in cohorts of at least 3 patients.

Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer

Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer (SCLC) Patients: a Phase I Trial.

Maastricht Radiation Oncology

250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks.

250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks

Albert DeNittis, MD

This research is being done to determine if a short course of Chloroquine (five weeks) before, during and after whole brain radiation therapy (WBRT) will improve the overall survival of subjects being treated for brain metastases.

Hypothesis one: A short course of chloroquine one week prior and four weeks after initiation of WBRT is tolerable and significantly increases the median survival time of patients suffering from brain metastasis as assessed one, three, six, nine, twelve and 24 months post radiotherapy, when compared to historic controls.

Hypothesis two: The presence of one or both single-nucleotide polymorphisms (SNP)s in the gene coding for the immunoregulatory enzyme indoleamine 2,3-dioxygenase 2 (IDO2) improves the clinical outcomes of WBRT or the response to CQ co-treatment.

3.2. Specific Aims:

The specific aims of this study are:

1. Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy.
2. Record the status of patient metastases (i.e. number, location, size)
3. Determine patients' KPS values.
4. Record the incidence and causes of mortality of patients.
5. Determine the genotype of IDO2 for each patient.
6. Following data analysis, test the validity of the two hypotheses.

IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine (CQ) in Brain Metastasis Radiotherapy

IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine in Brain Metastasis Radiotherapy.

Record the status of patient metastases (i.e. number, location, size)

Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy

Main Line Health

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Necrosis

Arthritis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Pharmaceutical Solutions

Dermatologic Agents

Reproductive Control Agents

Gastrointestinal Agents

Micronutrients

Hematinics

Vitamins

Hydroxychloroquine

Methotrexate

Tumor Necrosis Factor Inhibitors

Sulfasalazine

Leflunomide

Azathioprine

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Sarilumab 200 milligram (mg) subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other csDMARD during the randomized 6-month (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.

Pharmaceutical form:Solution for injection in pre-filled syringe Route of administration: Subcutaneous

SARILUMAB

Pharmaceutical form:Tablet Route of administration: Oral

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous / Intramuscular

Clinical Sciences & Operations

Primary Objective:

To assess the effect of sarilumab in combination with conventional synthetic Disease-Modifying Anti-Rheumatic Drug (csDMARD) and/or monotherapy on participant-reported impact of disease, using the rheumatoid arthritis impact of disease (RAID) questionnaire, in participants with moderately to severely active rheumatoid arthritis (RA) and inadequate response or intolerance to current csDMARD or tumor necrosis factor (TNF) inhibitors.

Secondary Objectives:

* To assess the change of the RAID score from baseline (to Week 4, Week 12, and Week 24) in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors, treated with sarilumab in combination with csDMARD and/or monotherapy.
* To assess the effect of sarilumab in combination with csDMARD and/or monotherapy on other participant-reported outcomes (global assessment of disease activity, disability, morning stiffness, fatigue, anxiety/depression, mood disorders, and physical activities) in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
* To assess the efficacy of sarilumab in combination with csDMARD and/or monotherapy using disease activity score-28 for RA with erythrocyte sedimentation rate (DAS28-ESR) and clinical disease activity index in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
* To assess the safety of sarilumab in combination with csDMARD and/or monotherapy in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.

The study duration per participant was approximately 32 weeks, with up to 4-week screening, 24 weeks treatment period, and 2-4 weeks post-treatment observations.

Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

Effect of Sarilumab on Patient-reported Outcomes in Patients With Moderately to Severely Active Rheumatoid Arthritis and With Inadequate Response or Intolerance to Current Conventional Synthetic DMARDs or Tumor Necrosis Factor Inhibitors

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological well-being, • sleep disturbance, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.

RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological well-being, • sleep disturbances, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.

RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological wellbeing, • sleep disturbance, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.

HADS questionnaire measures the presence and severity of anxiety and depression in both hospital and community settings. The questionnaire comprised of 14 items divided into 2 subscales: 7 items for anxiety subscale (HADS-A) and 7 items for depression subscale (HADS-D). Each item was scored on a 0 to 3 rating scale. The anxiety and depression subscales each ranged from 0 to 21 (0-7: normal, 8-10: borderline abnormal and 11-21: abnormal), where higher scores indicated greater severity of anxiety/depression. The subscales were independent for each result of depression and anxiety.

MAThyS was a multi-dimensional self-administered questionnaire comprised of five dimensions (emotional reactivity, cognition speed, psychomotor function, motivation and sensory perception) divided into 20 items relating to individual states as perceived by participants for the preceding week (at each specified Week). Each item was measured on a visual analog scale (VAS; in centimeters \[cm\]) ranged from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state). Total MAThyS score was sum of the 20 items and that might vary from score range 0 to 200 with lower scores indicated general inhibition and higher scores indicated general excitation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chloroquine in Combination With VELCADE and Cyclophosphamide for Relapsed and Refractory Multiple Myeloma	NCT01438177	Multiple Myelom...	Velcade Cyclophosphamid... Chloroquine	18 Years -	NYU Langone Health
Chloroquine for Treatment of Glioblastoma Multiforme	NCT00224978	Glioblastoma Mu...	Chloroquine	18 Years - 65 Years	National Institute of Neurology and Neurosurgery, Mexico
Study of Whole-brain Irradiation With Chloroquine for Brain Metastases	NCT01894633	Brain Metastasi...	Chloroquine Total brain rad...	46 Years - 61 Years	Instituto Nacional de Cancerologia de Mexico
Study of Whole-brain Irradiation With Chloroquine for Brain Metastases	NCT01894633	Brain Metastasi...	Chloroquine Total brain rad...	46 Years - 61 Years	Instituto Nacional de Cancerologia de Mexico
Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors	NCT02071537	Malignant Neopl... Solid Tumors	Chloroquine Carboplatin Gemcitabine	18 Years -	University of Cincinnati
Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer	NCT01575782	Small Cell Lung...	Chloroquine	18 Years -	Maastricht Radiation Oncology
IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine (CQ) in Brain Metastasis Radiotherapy	NCT01727531	Brain Metastasi...	Chloroquine dip...	18 Years -	Main Line Health
Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis	NCT03449758	Rheumatoid Arth...	SARILUMAB Azathioprine Chloroquine Hydroxychloroqu... Leflunomide Methotrexate Sulfasalazine	18 Years -	Sanofi
Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors	NCT02071537	Malignant Neopl... Solid Tumors	Chloroquine Carboplatin Gemcitabine	18 Years -	University of Cincinnati
Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis	NCT03449758	Rheumatoid Arth...	SARILUMAB Azathioprine Chloroquine Hydroxychloroqu... Leflunomide Methotrexate Sulfasalazine	18 Years -	Sanofi
Adjuvant Effect of Chloroquine on Gemcitabine	NCT01777477	Pancreatic Canc...	Chloroquine Gemcitabine	18 Years -	University of Zurich

Spots Global Cancer Trial Database for chloroquine

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

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