Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Rituximab

Vincristine

Pixantrone

Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles

CPOP-R

Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles

CHOP-R

Gabor Jurida, M.D.

The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R.

In preclinical studies, pixantrone has shown significantly less cardiotoxicity than other anthracyclines or anthracenediones. In addition, patients with relapsed disease, who have received prior maximum doses of anthracyclines, have tolerated high doses of pixantrone with minimal added cardiotoxicity. Pixantrone is currently being studied in a Phase III study in 3rd line aggressive NHL.

A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin

Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Plus Rituximab (CHOP-R) and Cyclophosphamide, Pixantrone, Vincristine, Prednisone Plus Rituximab (CPOP-R) in Patients With Diffuse Large-B-cell Lymphoma: A Phase II, Randomized, Multicenter, Comparative Trial

Overall Survival time frame is from the interval between the date of randomization and death due to any cause and measures the total number of deaths.

The interval between the date of randomization and the event of disease progression or relapse, institution of a new anticancer treatment or death.

CTI BioPharma

CPOP-R: Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles

CHOP-R: Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles

Total

≤ 65 Years

>65 Years

Age, Customized

Sex: Female, Male

Caucasian

Hispanic

Black

Asian

Other

Race/Ethnicity, Customized

Anton Egorov, Associate Project Director Clinical Development

Complete Response

Complete Response Unconfirmed

Response Rate

Overall Survival

Median Progression Free Survival (PFS)

Overall Objective Response Rate

Time to Treatment Failure

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA)

Tissue sample collected bronchoscope using needle aspirate of lung lymph gland, procedure takes 1 hour.

EBUS-TBNA

George A. Eapen, M.D.

The goal of this clinical research study is to learn how accurately an endobronchial ultrasound transbronchial needle aspiration (EBUS -TBNA) may detect mediastinal lymph node metastases in patients with clinical stage I and II non-small cell lung cancer (NSCLC).

Study Procedures:

A procedure called EBUS-TBNA has been developed that might allow doctors to get samples of lymph glands without performing an operation. The standard practice is a surgical operation called a mediastinoscopy. If researchers find out that EBUS-TBNA is as accurate as mediastinoscopy, it may mean that patients with lung cancer can avoid having surgery or will be able to get treatment before surgery.

EBUS-TBNA:

If you agree to take part in this study, you will first have an EBUS-TBNA. This will be performed on an out-patient basis under general anesthetic. The doctor will examine your lungs for suspicious lymph glands with an ultrasound, and then will take a sample of tissue from the lymph gland. This will be done using a flexible scope called a bronchoscope that can be passed into the windpipe. The lymph glands around the wind pipe can be seen and then removed with a small needle. The procedure should take about 1 hour.

Researchers will then analyze the lymph glands that were removed. Depending on whether or not the lymph glands have cancer in them, your doctor will then recommend the most appropriate therapy for you. This may include mediastinoscopy or some other appropriate therapy.

All the data for the study will be stored with a password protected system.

Length of Study:

Your participation in this study will be over after you have completed EBUS-TBNA.

This is an investigational study. EBUS-TBNA is FDA approved for this procedure.

Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.

Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)

Diagnostic Utility of Endobronchial Ultrasound Guided Mediastinal Lymph Node Sampling in Clinical Stage I and II Non Small Cell Lung Cancer

False negative rate estimated using EBUS guided mediastinal lymph node biopsy following a negative positron emission tomography (PET) scan with a 90% credible interval.

M.D. Anderson Cancer Center

Patients are treated with 48 mg/m2 of the drug SNS-595 injection once every 21 days for up to 6 cycles as a second -line therapy to patients with advanced non-small cell lung cancer (NSCLC)

Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis.

SNS-595 Injection

Glenn Michelson, MD

The purpose of this study is to evaluate the objective tumor response rate (based on the RECIST criteria) to SNS-595 as a second-line therapy in patients with advanced NSCLC.

Other objectives of this study are to assess the safety, tumor response, time to disease progression, survival rate and to explore several potential biomarkers to see how these levels change after administration of SNS-595.

Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC

Phase 2 Open-Label, Multicenter Clinical Study of the Safety and Efficacy of the Intravenous Administration of SNS-595 as Second-Line Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

ORR is based on RECIST criteria to SNS-595 as a second-line therapy in patients with advanced NSCLC. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) assessed by CT or 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.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions; \>=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (PD); Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (SD). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).

Sunesis Pharmaceuticals

Open label administration of SNS-595 48 mg/m2 treatment on day one of 21 day cycles, up to 6 cycles.

Age, Continuous

Race (NIH/OMB)

Statistical fields are not included here because no statistical testings were performed to compare any treatment group. No p-values or odds ratios were reported.

Mike Johnston, Senior Director Regulatory Affairs

Objective Tumor Response Rate

Best Overall Response

Patients are treated with 48 mg/m2 of the drug SNS-595 injection once every 21 days for up to 6 cycles as a second -line therapy to patients with advanced non-small cell lung cancer (NSCLC)

SNS-595 Injection: Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin	NCT00268853	Diffuse Large-C...	CPOP-R CHOP-R	18 Years -	CTI BioPharma
Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)	NCT00832715	Lung Cancer	EBUS-TBNA	18 Years -	M.D. Anderson Cancer Center
Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC	NCT00252382	Carcinoma, Non-...	SNS-595 Injecti...	18 Years -	Sunesis Pharmaceuticals

Spots Global Cancer Trial Database for large cell

Every month we try and update this database with for large cell 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 large cell

Every month we try and update this database with for large cell 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 large cell 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.