Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Anti-Infective Agents

Vitamins

Herbal and Botanical

Capecitabine

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Folic Acid

Pentamidine

Clotrimazole

Miconazole

Antifungal Agents

Antiprotozoal Agents

Antiparasitic Agents

Folinic Acid

Folate

Vitamin B9

Cola

Use of pentamidine in second and/or third line metastatic colon cancer

one dose of 4 mg/kg to two dose of 4 mg/kg with possibility of escalated to two dose of 6 mg/kg with or without standard chemotherapy.

pentamidine

Petr Kavan, MD, Ph.D.

The purpose of this study is to investigate the safety and possible efficacy of the use of pentamidine in the treatment of colon cancer metastasis in subjects receiving standard therapy.

A Safety Study of Pentamidine in Patients With Metastatic Colon Cancer Undergoing Standard Chemotherapy as Second-line and/or Third-line Treatment

A Phase I/II Clinical Study Using Pentamidine in Patients With Metastatic Colon Cancer Undergoing Standard Folinic Acid, 5-Fluorouracil, or Capecitabine and Oxaliplatin Chemotherapy as Second-line and/or Third-line Treatment

Oncozyme Pharma Inc.

Dr. Terry Chow/President

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Edward A. Sausville, MD, PhD

RATIONALE: Drugs used in chemotherapy, such as pentamidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well pentamidine works in treating patients with relapsed or refractory melanoma.

OBJECTIVES:

Primary

* To determine the response rate in patients with relapsed or refractory melanoma that expresses wild-type p53 and S100 calcium binding protein B (S100B) treated with pentamidine.

Secondary

* To observe the effect of this drug on the expression of S100B and p21 in tumor biopsy samples.
* To observe the effect of this drug on S100B detectable in serum.
* To observe the time to progression in these patients.
* To assess the toxicities associated with the administration of this drug in these patients.

OUTLINE: Patients receive pentamidine IV over 2 hours 5 days a week for 2 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative laboratory studies. Samples are assessed for p53 status and S100B, p53, and p21 expression by immunohistochemistry, polymerase chain reaction, western blotting, luminescence assay, and ELISA.

After completion of study treatment, patients are followed for 30 days.

This is an open label Phase II trial that will utilize a Simon two stage acquisition of patients with evaluable relapsed and/or refractory melanoma.

0794GCC: Pentamidine in Treating Patients With Relapsed or Refractory Melanoma

Treatment of Melanoma With Wild-type p53 and Detectable S100B Using Pentamidine: a Phase II Trial With Correlative Biomarker Endpoints

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum of the longest diameter since the treatment started. (Therasse, P., Arbuck, S.G., Eisenhauer, E.A., Wanders, J., Kaplan, R.S., Rubinstein, J., Van Glabbeke, M., van Oosterom, A.T., Christian, M.C., Gwyther, S.G. (2000) J Natl Cancer Inst 92, 205-16)

Core needle tumor biopsy - at Day 12 at first cycle of treatment

Radiologic intervention using RECIST (x-ray, CT, MRI)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

National Cancer Institute (NCI)

University of Maryland, Baltimore

Pentamidine isethionate will be administered at a dose of 4 mg/kg/day over 120 minutes each day, Monday - Friday for two weeks followed by a drug free period of 2 weeks.

Treatment Arm

Patients will receive 4 mg/kg/day IV pentamidine isethionate infused slowly over 2 hours on each treatment day. Each treatment cycle will consist of 2 weeks of therapy, five days per week, followed by 2 weeks of observation.

Age, Continuous

Sex: Female, Male

Unable to reach the target number of participants needed before study was closed at the suggestion of DSMB

Edward A. Sausville, M.D., Ph.D.

Response Rate in Patients Treated With Pentamidine

Only data for 1 site was analyzed for this outcome measure

Number of Participants With Both p21 and S100B Expression in Accessible Tumor Biopsies Pre Pentamidine Exposure in Cycle 1

Only 1 participant from 1 site had a biopsy collected and analyzed

Number of Participants With p21 and S100B Expression in Accessible Tumor Biopsies Post Pentamidine Exposure

Only data for 1 site was analyzed for this outcome measure.

Expression of S100B Pre Pentamidine Exposure

C1D8

C1D12

C2D8

C2D12

Only data from 1 site was analyzed for this outcome measure

Expression of S100B

Number of Participants With Serious and Non Serious Adverse Events

Time to Progression

Overall Study

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Use of pentamidine in locally advanced or metastatic pancreatic cancer

two dose of 6 mg/kg with or without standard chemotherapy.

The purpose of this study is to investigate the safety and possible efficacy of the use of pentamidine in the treatment of pancreatic cancer metastasis in subjects receiving standard therapy.

A Safety Study Using Pentamidine in Patients With Pancreatic Cancer Undergoing Standard Therapy

A Phase I/II Clinical Study Using Pentamidine in Patients With Locally Advanced or Metastatic Pancreatic Cancer Undergoing Standard Therapy

Blood and Lymph Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Hematologic Neoplasms

Pneumonia, Pneumocystis

Pneumonia

Communicable Diseases

Respiratory Tract Infections

Lung Diseases

Respiratory Tract Diseases

Hematologic Diseases

Lung Diseases, Fungal

Mycoses

Bacterial Infections

Bacterial Infections and Mycoses

Pneumocystis Infections

Pneumocystis Jirovecii Pneumonia

Pneumocystosis

Anti-Bacterial Agents

Pentamidine 4mg/kg IV every month (maximum 300mg)

Pentamidine is an antimicrobial medication given for prevention and treatment of Pneumocystis pneumonia (PJP) caused by Pneumocystis jirovecii

Jennifer Anderson, PharmD

The main objective of this study is to assess the safety of administering intravenous (IV) pentamidine for Pneumocystis jirovecii pneumonia (PJP) prophylaxis in adult inpatients with hematologic malignancies and stem cell transplant recipients. There will also be an assessment of patient satisfaction associated with intravenous pentamidine PJP prophylactic therapy.

This study is a prospective, single arm study to assess safety of IV pentamidine for PJP prophylaxis. Patient satisfaction associated with IV pentamidine will also be assessed using a survey adapted from the validated Treatment Satisfaction Questionnaire for Medication (version 1.4).

Adult patients with a hematologic malignancy or who are receiving or have received a stem-cell transplant at the University of Illinois Hospitals and Clinics who have an indication for PJP prophylaxis therapy. They will receive intravenous pentamidine during their planned admissions for chemotherapy when they have an indication for and/or are due to receive pentamidine prophylaxis. These patients are outlined below in the inclusion criteria. Patients may or may not have received aerosolized or IV pentamidine prior to inclusion in the study.

Eligible patients will receive IV pentamidine during hospital admissions. Patients will be routinely monitored by nursing staff during and after the infusion. Nursing staff will monitor the systolic and diastolic blood pressure at baseline and one hour post infusion. Patients will also be monitored for nausea/vomiting. Patients who receive IV pentamidine will have anti-emetics available on call to use in the event that they become nauseous. Data will be collected on the type, grade, and incidence of adverse effects by research personnel.

Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia

Assessment of the Safety and Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia in Patients With Hematologic Malignancies and Stem Cell Transplant Recipients.

Safety will be assessed via analyzing the number of patients experiencing adverse effects, with their severity graded using CTCAE v4.0.

University of Illinois at Chicago

PharmD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety Study of Pentamidine in Patients With Metastatic Colon Cancer Undergoing Standard Chemotherapy as Second-line and/or Third-line Treatment	NCT00809796	Colorectal Canc...	pentamidine	18 Years -	Oncozyme Pharma Inc.
0794GCC: Pentamidine in Treating Patients With Relapsed or Refractory Melanoma	NCT00729807	Melanoma (Skin)	pentamidine	18 Years - 120 Years	University of Maryland, Baltimore
A Safety Study Using Pentamidine in Patients With Pancreatic Cancer Undergoing Standard Therapy	NCT00810953	Pancreatic Canc...	Pentamidine	18 Years -	Oncozyme Pharma Inc.
Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia	NCT02669706	Hematologic Mal...	Pentamidine	18 Years -	University of Illinois at Chicago
A Safety Study of Pentamidine in Patients With Metastatic Colon Cancer Undergoing Standard Chemotherapy as Second-line and/or Third-line Treatment	NCT00809796	Colorectal Canc...	pentamidine	18 Years -	Oncozyme Pharma Inc.

Spots Global Cancer Trial Database for pentamidine

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

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