Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Prolymphocytic

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Antirheumatic Agents

All Drugs and Chemicals

Auranofin

Auranofin 6 mg orally in the morning / 6 mg orally in the evening

6 mg twice a day for a total of 12 mg total daily dose

auranofin

Suman Kambhampati, MD

The purpose of this study is to evaluate the safety and effectiveness of auranofin to treat patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or prolymphocytic lymphoma (PLL).

Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)

A Phase I Phase II Two-Step Study of the Oral Gold Compound Auranofin in Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)/ Prolymphocytic Lymphoma (PLL)

The Leukemia and Lymphoma Society

Kansas Bioscience Authority

Therapeutics for Rare and Neglected Diseases (TRND)

University of Kansas Medical Center

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anti-Infective Agents

Antineoplastic Agents

Sirolimus

Temsirolimus

MTOR Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Immunosuppressive Agents

Immunologic Factors

Patients receive auranofin PO QD and sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

sirolimus

laboratory biomarker analysis

pharmacological study

Michael E Menefee, M.D.

This phase I clinical trial studies the side effects and best dose of auranofin and sirolimus when given together in treating patients with non-small cell lung cancer. Immunosuppressive therapy, such as auranofin and sirolimus, may be an effective treatment for non-small cell lung cancer. Sirolimus may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving auranofin and sirolimus may be an effective treatment for non-small cell lung cancer.

PRIMARY OBJECTIVES:

I. To determine the maximally tolerated dose (MTD) of auranofin plus sirolimus (Cohort I).

II. To determine the confirmed response rate of auranofin plus sirolimus (Cohort II).

SECONDARY OBJECTIVES:

I. To describe the adverse event and toxicity profiles associated with this treatment combination.

II. To evaluate response, time to progression, progression-free survival (PFS), overall survival (OS), and time to treatment failure in patients treated with this treatment combination.

TERTIARY OBJECTIVES:

I. To evaluate tumor biomarkers of protein kinase C (PKC) and mammalian target of rapamycin (mTOR) signaling activity as predictors of clinical outcome (i.e. response, PFS, OS) for patients receiving auranofin/sirolimus therapy.

II. To evaluate the use of surrogate biomarkers of PKC and mTOR inhibition in peripheral blood lymphocytes (PBLs) as predictors of clinical outcome (i.e. response, PFS, OS) for patients receiving auranofin/sirolimus therapy.

OUTLINE: This is a cohort I, dose-escalation study followed by a cohort II study.

Patients receive auranofin orally (PO) once daily (QD) and sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for 2 years.

Auranofin and Sirolimus in Treating Patients With Advanced Solid Tumors or Recurrent Non-Small Cell Lung Cancer

Phase I Study of Auranofin and Sirolimus in Adult Patients With Non-Small Cell Lung Cancer

Will be estimated by the number of confirmed responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

The number and severity of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized. The grade 3+ adverse events will also be described and summarized in a similar fashion.

Overall toxicity incidence as well as toxicity profiles by dose level, patient, and tumor site will be explored and summarized. Frequency distributions, graphical techniques, and other descriptive measures will form the basis of these analyses.

Will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population (overall, by tumor group, and by cohort).

Will be summarized descriptively using Kaplan Meier methodology, the log-rank test, and Cox Proportional Hazards models (where appropriate given the small sample size).

National Cancer Institute (NCI)

Mayo Clinic

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Glandular and Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Patients receive auranofin PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Aminah Jatoi, M.D.

This pilot clinical trial studies auranofin in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer. Immunosuppressive therapy, such as auranofin, may be an effective treatment for epithelial ovarian, primary peritoneal, or fallopian tube cancer.

PRIMARY OBJECTIVES:

I. To demonstrate the feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients with cancer antigen (CA 125) elevation.

SECONDARY OBJECTIVES:

I. To explore whether oral gold therapy either stabilizes or lowers the CA 125 level and maintains patients in an asymptomatic state and to provide descriptive data on tumor response and duration of response.

II. To acquire qualitative data on patients' perceptions of learning of CA 125 elevation.

III. To explore whether immunohistochemical staining for PKC iota expression in resected tumor samples appears to be associated with clinical outcomes with auranofin.

OUTLINE:

Patients receive auranofin orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

A Pilot Trial to Evaluate the Feasibility Auranofin (Ridaura®) for Asymptomatic Patients With First-Recurrence Epithelial Ovarian Cancer

To demonstrate the feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients with CA 125 elevation. This study could potentially serve as a paradigm to investigate agents that might eventually be used as maintenance therapy in patients at high risk for recurrent disease.

To explore whether immunohistochemical staining for PKCt expression in resected tumor samples appears to be associated with clinical outcomes with Auranofin.

To explore whether oral gold therapy either stabilizes or lowers the CA 125 level and maintains patients in an asymptomatic state and to provide descriptive data on tumor response and duration of response.

Participants receive auranofin PO QD and sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.

Laboratory Biomarker Analysis

This phase II trial studies how well auranofin and sirolimus work in treating participants with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to decrease the body?s immune response and may increase blood cell count.

PRIMARY OBJECTIVES:

I. To estimate the overall tumor response rate (ORR, that is, complete response \[CR\] + partial response \[PR\]) of the combination of auranofin and sirolimus in the setting of metastatic serous ovarian cancer across all patients.

SECONDARY OBJECTIVES:

I. To estimate the overall tumor response rate (ORR, that is, complete response \[CR\] + partial response \[PR\]) of the combination of auranofin and sirolimus in the setting of metastatic serous ovarian cancer within patients that have overexpression of PKCiota.

II. To estimate progression-free survival, overall survival, and adverse events from the combination of auranofin and sirolimus.

CORRELATIVE OBJECTIVES:

I. To explore whether PKCiota-relevant biomarkers in serous ovarian cancer tumors are associated with treatment response patterns, such as ORR, progression free survival, and overall survival.

OUTLINE:

Participants receive auranofin orally (PO) once daily (QD) and sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.

After completion of study treatment, participants are followed up every 6 months for 3 years.

Auranofin and Sirolimus in Treating Participants With Ovarian Cancer

Phase II Trial to Evaluate the Efficacy of Auranofin and Sirolimus in Serous Ovarian Cancer Patients With Recurrent Disease

The outcome measure is the number of participants with a confirmed tumor response (partial response \[PR\] or complete response \[CR\] at least 4 weeks apart). PR and CR are defined using RECIST 1.1 criteria. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target and non-target lesions and normalisation of tumour marker level. Any pathological lymph nodes must have reduction in short axis to \<10 mm.

The outcome measure is the number of participants with a confirmed tumor response (partial response \[PR\] or complete response \[CR\] at least 4 weeks apart) in the subset of participants that have overexpression of PKC iota. PR and CR are defined using RECIST 1.1 criteria. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target and non-target lesions and normalisation of tumour marker level. Any pathological lymph nodes must have reduction in short axis to \<10 mm.

Progression-free survival (PFS) is defined as the time from registration to the first of either disease progression or death from any cause. Patients who receive the study drug, but then never return for an evaluation will be censored on their last follow-up date. PFS will be estimated using the method of Kaplan-Meier. Progression is defined using RECIST 1.1 criteria; Progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression), Unequivocal progression (see comments below) of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression), or appearance of new malignant lesions.

Overall survival (OS) is defined as the time from registration to death from any cause. OS will be estimated using the method of Kaplan-Meier.

The outcome measure is the number of participants experiencing at least one grade 3 or worse adverse event (AE).

Participants evaluable for adverse events are summarized below (i.e. participants who did not withdraw consent).

Participants receive 6 mg auranofin PO QD and 5 mg sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.

Treatment (Auranofin, Sirolimus)

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Received prior chemotherapy for this cancer

Tumor Over-expression of Protein Kinase C (PKC) iota

Aminah Jatoi MD

Number of Participants With a Confirmed Tumor Response (Partial Response [PR] or Complete Response [CR] at Least 4 Weeks Apart)

Number of Participants With a Confirmed Tumor Response (PR or CR at Least 4 Weeks Apart) in the Subset of Participants That Have Over-expression of Protein Kinase C (PKC) Iota

Progression-free Survival (PFS)

Overall Survival (OS)

Number of Participants Experiencing at Least One Grade 3 or Worse Adverse Event (AE)

Overall Study

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

Antiemetics

Gastrointestinal Agents

Antihypertensive Agents

Psychotropic Drugs

Anti-Inflammatory Agents

Analgesics

Alcohol Deterrents

Central Nervous System Depressants

Ritonavir

Temozolomide

Aprepitant

Itraconazole

Captopril

Sertraline

Celecoxib

Disulfiram

Minocycline

Hydroxyitraconazole

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Cytochrome P-450 CYP3A Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Hormones

Hormone Antagonists

Antidepressive Agents

Selective Serotonin Reuptake Inhibitors

Serotonin

Neurotransmitter Agents

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Angiotensin-Converting Enzyme Inhibitors

Ethanol

After enrollment, the subject goes into the induction cycle, which lasts 35 days. The induction cycle consists of a drug-by-drug addition and up-dosing process.

Hereafter, the subject will enter the treatment cycles (up to 12). During the induction cycle and the first 2 treatment cycles, regimen adjustments (dropping of certain drugs, dose modification of certain drugs) may be executed to accommodate to the patients' individual toxicity reactions that may occur during this period.

Patients will receive temozolomide at a dose of 20 mg/m² BSA twice daily with start day 1 during induction and treatment cycles

Patients will receive aprepitant at a dose of 80 mg p.o. once daily with start day 1 during induction and treatment cycles

Induction cycle day 3-4: minocycline 50 mg p.o. twice daily from day 19-20; minocycline 100 mg p.o. twice daily during treatment cycle 1-12 (28 days); minocycline 100 mg p.o. twice daily

Induction cycle day 5-6: disulfiram 250 mg p.o. once daily from day 21-22; disulfiram 250 mg p.o. twice daily during treatment cycle 1-12 (28 days); disulfiram 250 mg p.o. twice daily

Induction cycle day 1-35: day 7-8: celecoxib 200 mg p.o. twice daily from day 23-24; celecoxib 400 mg p.o. twice daily during treatment cycle 1-12 (28 days); celecoxib 400 mg p.o.twice daily

Induction cycle day 1-35: day 9-10: sertraline 50 mg p.o. twice daily, day 31-32: sertraline 100 mg p.o. twice daily; treatment cycle 1-12: sertraline 100 mg p.o. twice daily

Induction cycle day 1-35: day 11-12: captopril 25 mg p.o. twice daily, day 25-26: captopril 50 mg p.o. twice daily; treatment cycle 1-12 (28 days): captopril 50 mg p.o. twice daily

Induction cycle day 1-35: day 13-14: itraconazole 200 mg p.o. once daily day 27-28; itraconazole 200 mg p.o. twice daily; treatment cycle 1-12 (28 days): itraconazole 200 mg p.o.twice daily

Induction cycle day 1-35: day 15-16: ritonavir 200 mg p.o. once daily, day 29-30: ritonavir 200 mg p.o. twice daily, day 35: ritonavir 400 mg p.o. twice daily; treatment cycle 1-12 (28 days): ritonavir 400 mg p.o. twice daily

Induction cycle day 1-35: day 17-18: auranofin 3 mg p.o. once daily, day 33-34 auranofin 3 mg p.o. twice daily; treatment cycle 1-12 auranofin 3 mg p.o. twice daily

Marc-Eric Halatsch, MD

A proof-of-concept clinical trial assessing the safety of the coordinated undermining of survival paths by 9 repurposed drugs combined with metronomic temozolomide (CUSP9v3 treatment protocol) for recurrent glioblastoma

A proof-of-concept clinical trial assessing the safety of the coordinated undermining of survival paths by 9 repurposed drugs (aprepitant, auranofin, captopril, celecoxib, disulfiram, itraconazole, minocycline, ritonavir and sertraline) combined with metronomic temozolomide (CUSP9v3 treatment protocol) for recurrent glioblastoma. This is a phase I study for subjects of 18 years and older with glioblastoma that has relapsed after radiation and chemotherapy, as confirmed by histology and MRI.

A total of 10 patients will be treated with the CUSP9v3 treatment protocol. This is a monocentric trial: all patients will be treated at Ulm University Hospital.

A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma

* either any unmanageable grade 3-4 toxicity at the end of the second treatment cycle
* or inability to receive at least 7 of the 10 drugs, all of them being given at ≥50% of the target doses at the end of the second treatment cycle
* Modifications in terms of doses and/or number of drugs are accepted at any time during treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)	NCT01419691	Chronic Lymphoc... Small Lymphocyt... Leukemia, Proly...	auranofin	18 Years -	University of Kansas Medical Center
Auranofin and Sirolimus in Treating Patients With Advanced Solid Tumors or Recurrent Non-Small Cell Lung Cancer	NCT02126527	Recurrent Non-s... Unspecified Adu...	auranofin sirolimus laboratory biom... pharmacological...	18 Years -	Mayo Clinic
Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer	NCT01747798	Recurrent Fallo... Recurrent Ovari... Recurrent Prima...	auranofin laboratory biom...	18 Years -	Mayo Clinic
Auranofin and Sirolimus in Treating Patients With Advanced Solid Tumors or Recurrent Non-Small Cell Lung Cancer	NCT02126527	Recurrent Non-s... Unspecified Adu...	auranofin sirolimus laboratory biom... pharmacological...	18 Years -	Mayo Clinic
Auranofin and Sirolimus in Treating Participants With Ovarian Cancer	NCT03456700	Ovarian Serous ... Recurrent Ovari...	Auranofin Laboratory Biom... Sirolimus	18 Years -	Mayo Clinic
A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma	NCT02770378	Glioblastoma	Temozolomide Aprepitant Minocycline Disulfiram Celecoxib Sertraline Captopril Itraconazole Ritonavir Auranofin	18 Years -	University of Ulm

Spots Global Cancer Trial Database for auranofin

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

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