Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Anti-Allergic Agents

Antiemetics

Central Nervous System Depressants

Gastrointestinal Agents

All Drugs and Chemicals

Dermatologic Agents

Antineoplastic Agents

Anticoagulants

Anti-Infective Agents

Other Dietary Supplements

Diphenhydramine

Promethazine

Ranitidine

Ranitidine bismuth citrate

Epothilones

Epothilone B

Bismuth

Citric Acid

Sodium Citrate

Bismuth tripotassium dicitrate

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Antacids

Anti-Ulcer Agents

Histamine H2 Antagonists

Citrate

One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m\^2/day for a total per cycle dose of 30 mg/m\^2

BMS-247550

50 mg 30-60 minutes prior to Ixabepilone (BMS-247550)

50 mg intravenously 30-60 minutes prior to Ixabepilone (BMS-247550)

Tito Fojo, M.D.

This study will examine whether the experimental drug BMS 247550 (Ixabepilone) is an effective treatment for kidney cancer. BMS 247550 belongs to a class of drugs called epothilones that interfere with the ability of cancer cells to divide. In the way they kill cells, they are very similar to a class of compounds known as the taxanes, which include the drug Taxol. Other characteristics of the epothilones, however, enable them to work in cells that are resistant to Taxol.

Patients 18 years of age or older with kidney cancer that has not spread to the central nervous system (unless the brain tumor has remained stable for at least six months after surgical or radiation treatment) may be eligible for this study. Pregnant or nursing women may not participate. Candidates are screened with various tests that may include blood and urine tests, electrocardiogram (EKG), and chest x-ray. Computerized tomography (CT) scans or X-rays, and possibly nuclear medicine studies may be done to determine the extent of disease.

Participants receive BMS 247550 by a 1-hour infusion into a vein for 5 consecutive days (days 1, 2, 3, 4 and 5) of each 21-day treatment cycle. Patients must stay in the National Institutes of Health (NIH) area near Bethesda, Maryland, for 7 to 8 days during the first treatment cycle and for the 5 days of treatment in subsequent cycles. The total number of cycles will vary among patients, depending on their individual clinical situation. The drug dose may be increased gradually in subsequent cycles in patients who can tolerate such increases. In addition, participants undergo the following tests and procedures:

* Periodic physical examinations and frequent blood tests
* X-ray and other imaging studies to determine if the tumor is responding to the treatment.
* Tumor biopsies to confirm the diagnosis or spread of tumor and to examine the reaction of certain proteins in cancer cells to BMS 247550. Two biopsies will be done. For this procedure, a small piece of tumor tissue is withdrawn through a needle under local anesthetic.

Treatment will be stopped in patients whose tumor grows while receiving BMS 247550. Patients whose tumor disappears completely will be followed at NIH periodically for examinations and tests. Patients whose disease does not completely resolve or whose disease recurs may be advised of other appropriate research protocols at NIH or, if none are available, will be returned to the care of their local doctor.

Background:

BMS-247550 (NSC 710428), (ixabepilone) is a semi-synthetic analog of the natural product epothilone B.

The epothilones are a novel class of non-taxane microtubule-stabilizing agents obtained from the fermentation of the cellulose degrading myxobacteria, Sorangium cellulosum.

BMS-247550 is active against cancer models that are naturally insensitive to paclitaxel or have developed resistance to paclitaxel, both in-vitro and in-vivo.

Objectives

Establish the efficacy of the investigational agent BMS-247550 in patients with renal cell carcinoma when administered as a one hour infusion on day 1 to 5 every 21 days.

Evaluate the plasma pharmacokinetics of BMS-247550.

Explore the pharmacodynamics of BMS-247550 using an assay that measures the amount of endogenous tubulin in peripheral blood mononuclear cells (PBMC) that exists in the polymerized versus the unpolymerized state.

Determine the extent to which pharmacodynamic changes are observed over a range of doses of BMS-247550.

Determine if cross-resistance to BMS-247550 exists in patients who have previously received sorafenib or sunitinib.

Eligibility:

Age greater than 18.

Pathological confirmation of renal cell carcinoma.

Prior chemotherapy including sorafenib and sunitinib is allowed.

Design:

Phase II study.

BMS-247550 will be administered on days 1 through 5, every 21 days.

Restaging will be done every two cycles.

BMS 247550 to Treat Kidney Cancer

A Phase II Clinical Trial of BMS-247550 (NSC 710428), an Epothilone B Analog, in Renal Cell Carcinoma

Response rate is the percentage of participants with a response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions, Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

National Cancer Institute (NCI)

Antonio T. Fojo, M.D./National Cancer Institute

Age, Categorical

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Caucasian

African American

Asian

Hispanic

Race/Ethnicity, Customized

United States

Region of Enrollment

Complete response

Partial Response

Progressive disease

Stable disease

Response Rate

Number of Participants With Adverse Events

Overall Study

Gland and Hormone Related Diseases

Digestive System Diseases

Ovarian Neoplasms

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Fallopian Tube Diseases

Ovarian Cancer

Tubulin Modulators

Antimitotic Agents

epothilone b

Novartis Pharmaceuticals

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.

EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).

duration of response in patients with complete response (CR) or partial response (PR)

Safety and tolerability of patupilone by monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry and urine lalues, vital signs, ECG and physical examinations

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

intravenous 2.5 mg/m2 as a 5 minutes bolus infusion once every week for three weeks followed by one week off

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause melanoma.

EPO906 Therapy in Patients With Advanced Melanoma

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Melanoma

Objective tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines assessed by radiologic techniques and/or physical examination.

Safety and tolerabilty of EPO906: Safety assessments consisted of monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs and the performance status.

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Androgens

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause prostate cancer.

EPO906 Therapy in Patients With Prostate Cancer

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Androgen-independent Prostate Cancer

Colorectal Neoplasms

Colonic Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Cola

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause colorectal cancer.

EPO906 Therapy in Patients With Advanced Colorectal Cancer

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Colorectal Cancer

External Affairs

Breast Neoplasms

Breast Diseases

Taxane

This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause breast cancer.

EPO906 Therapy in Patients With Advanced Breast Cancer

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Breast Cancer

EPO906 administered intravenously at 2.5 mg/m2 as a 5 minute bolus infusion repeated every week for three weeks followed by one week off The final tables and data is not in yet, so I cannot give you info on safety issues.

This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer.

EPO906 Therapy in Patients With Advanced Kidney Cancer

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer

Symptoms and General Pathology

Neoplasm Metastasis

Recurrence

Breast Neoplasms, Male

Neoplastic Processes

Breast Cancer, Male

Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.

epothilone B

David M. Peereboom, MD

Joseph Baar, MD

RATIONALE: Drugs used in chemotherapy, such as epothilone B, 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 epothilone B works in treating patients with CNS metastases from breast cancer.

OBJECTIVES:

Primary

* Determine the 3-month CNS-progression free survival of patients with CNS metastases secondary to breast cancer treated with epothilone B.

Secondary

* Determine the toxicity of this drug in these patients.
* Determine the CNS response rate and duration of CNS response in patients treated with this drug.
* Determine the systemic disease response rate and duration of systemic response in patients treated with this drug.
* Determine the overall survival of patients treated with this drug.

OUTLINE: This is a multicenter, open-label study.

Patients receive epothilone B IV over 20 minutes on day 1. Courses repeat every 21 days in the absence of disease progression, satisfactory response, or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Epothilone B in Treating Patients With CNS Metastases From Breast Cancer

Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer

The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as \<25% increase in tumor area.

PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death.

Percent of patients that experience the most common grade 3 and above toxicities possibly related to study drug - to be measured using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.

Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of \>50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a \> 25% increase in tumor area (two diameters)

Median time (months) that patients survived during the duration of the study.

David Peereboom, MD

Principal Investigator

Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.

Epothilone B (Groups A and B)

Age, Continuous

Race (NIH/OMB)

Group A

Group B

Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT) Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).

Central Nervous System (CNS) metastases

Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.

Epothilone B: Group A

Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.

Epothilone B: Group B

Central Nervous System (CNS) Progression-free Survival(PFS)

Toxicity as Measured by NCI CTCAE v3.0

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

CNS Response Rate, for Measurable Disease Will be Assessed by the Modified McDonald Criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BMS 247550 to Treat Kidney Cancer	NCT00030992	Renal Cell Carc...	BMS-247550 Ranitidine Diphenhydramine	18 Years -	National Institutes of Health Clinical Center (CC)
EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer	NCT00035100	Ovarian Neoplas... Peritoneal Neop... Fallopian Tube ...	epothilone b	18 Years -	Novartis
EPO906 Therapy in Patients With Advanced Melanoma	NCT00035165	Melanoma	epothilone b	18 Years - 85 Years	Novartis
BMS 247550 to Treat Kidney Cancer	NCT00030992	Renal Cell Carc...	BMS-247550 Ranitidine Diphenhydramine	18 Years -	National Institutes of Health Clinical Center (CC)
EPO906 Therapy in Patients With Prostate Cancer	NCT00035113	Prostatic Neopl...	epothilone b	18 Years - 85 Years	Novartis
EPO906 Therapy in Patients With Advanced Colorectal Cancer	NCT00035087	Colorectal Neop... Colonic Neoplas...	epothilone b	18 Years - 85 Years	Novartis
EPO906 Therapy in Patients With Advanced Breast Cancer	NCT00035126	Breast Neoplasm...	epothilone b	18 Years - 85 Years	Novartis
EPO906 Therapy in Patients With Advanced Kidney Cancer	NCT00035243	Kidney Neoplasm...	epothilone b	18 Years - 85 Years	Novartis
Epothilone B in Treating Patients With CNS Metastases From Breast Cancer	NCT00450866	Breast Cancer Metastatic Canc...	epothilone B	18 Years -	Case Comprehensive Cancer Center
EPO906 Therapy in Patients With Prostate Cancer	NCT00035113	Prostatic Neopl...	epothilone b	18 Years - 85 Years	Novartis
Epothilone B in Treating Patients With CNS Metastases From Breast Cancer	NCT00450866	Breast Cancer Metastatic Canc...	epothilone B	18 Years -	Case Comprehensive Cancer Center
EPO906 Therapy in Patients With Advanced Breast Cancer	NCT00035126	Breast Neoplasm...	epothilone b	18 Years - 85 Years	Novartis
EPO906 Therapy in Patients With Advanced Kidney Cancer	NCT00035243	Kidney Neoplasm...	epothilone b	18 Years - 85 Years	Novartis

Spots Global Cancer Trial Database for epothilone b

Every month we try and update this database with for epothilone b 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.