Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Neoplasm Metastasis

Central Nervous System Diseases

Brain Neoplasms

Breast Diseases

Skin Diseases

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Antineoplastic Agents

All Drugs and Chemicals

Epothilones

Sagopilone

Tubulin Modulators

Antimitotic Agents

Given intravenously over approximately 30 minutes once every 3 weeks

ZK219477

Nancy Lin, MD

The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.

* Participants will be given ZK219477 intravenously over approximately 30 minutes every three weeks.
* During all treatment cycles a physical exam and questions about the participants general health and specific questions about any problems they may be having will be performed.
* At least every three weeks blood tests will be done to assess the effect of ZK219477 on the body.
* After every 2 cycles of treatment, participants will have additional scans to assess the effect of ZK219477 on their cancer. This will include a CT scan of the abdomen, chest, and pelvis, and an MRI of the brain.
* At the time of the standard MRI, participants will be asked to undergo an additional MRI sequence, which means they will be in the MRI machine for approximately 15-20 more minutes.

ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases

A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases

Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.

Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease

Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0

CBR = CR + PR + SD \> 24 weeks in CNS with at least stable non-CNS disease

Brigham and Women's Hospital

Bayer

Breast Cancer Research Foundation

Assistant Professor of Medicine

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Nancy Lin

The study was closed prior to full accrual as detailed in the manuscript

Objective Response Rate in the Central Nervous System (CNS)

Study was closed prior to full accrual for reasons detailed in published manuscript

Number of Subjects With Adverse Events (Any Grade)

only included the 8 pts with measurable non-CNS disease at baseline. The 7 pts with non-measurable non-CNS disease at baseline were not included in the denominator for this endpoint

Objective Response Rate in Non-Central Nervous System (CNS) Sites

all patients who received at least 1 dose of protocol therapy

Time to Progression at Any Site.

all pts who received at least 1 dose of protocol therapy

Clinical Benefit Rate.

Overall Study

Rare Diseases

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

Neuroendocrine Tumor

Neuroepithelioma

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

Emetics

Ondansetron

Granisetron

ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m\^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.

Participants were treated with 16 mg/m\^2 of ZK-EPO (EpothiloneZK) (Sagopilone) administered as a single 3 hour intravenous infusion every 21 days. Prior to each treatment, participants were premedicated with either granisetron or ondansetron and additional anti-emetics if needed. Chemotherapy was continued until disease progression, withdrawal of consent, or for unacceptable treatment-associated toxicity.

ZK-EPO

Ronald DeConti, M.D.

The purpose of this study is to find out how effective an investigational drug named ZK-Epo is against melanoma. Although ZK-Epo has been studied in the treatment of cancer, it is not approved for use in treating melanoma. This research is being done because currently there are only a limited number of treatment options for patients who have melanoma that has spread to distant organs.

We expect each patient to be in this study for at least 2 cycles. One cycle lasts for 21 days. If their tumor does not grow after 2 cycles and they do not have any major side-effects, they may receive up to 6 cycles of ZK-Epo.

If after they have received 6 cycles of ZK-Epo and their doctor determines that the tumor is continuing to shrink, they will continue treatment with ZK-Epo. The number of treatments the patient receives after 6 cycles will depend upon when their doctor feels there has been maximum tumor response (tumor shrinkage). Two treatments will be given beyond what their doctor considers the point of maximum shrinkage. We estimate that they will spend anywhere from 1 1/2 months to 5 months taking part in this study.

Each Cycle is a 21 day period. On the first day of each cycle each patient will receive the study drug, ZK-Epo, through an IV infusion over a 3 hour period. Patients will receive the study drug only once every 21 day period.

At the start of each cycle patients will have the following tests:

* Patients will be asked questions about their medical history and health and undergo a complete physical exam.
* Blood tests will be done to check blood cell count and organ functions (about 1 tablespoon of blood will be taken).
* Performance status tests (will determine patient's ability to perform everyday functions).
* A nurse or doctor will ask patients how they are feeling and about any side effects that patients may be having.
* Pre Study Visit: Blood test called lactate dehydrogenase (LDH) to check organ function. Prothrombin time (PT) and an a partial thromboplastin time (PTT) to see if the patient's blood clots normally. Electrocardiogram (EKG) (to measure the electrical function of patient's heart). Pregnancy Test (IF APPLICABLE a woman of child bearing age). Optional Tumor Biopsy (If indicated by patient's physician).
* Cycle 1, Day 1: Pharmacokinetics: special blood tests to measure the drug levels, LDH
* Cycle 1, Day 2 \& 8: Pharmacokinetics
* Cycle 1, Day 15: EKG
* Cycle 2, DAY 1: LDH
* Cycle 3, DAY 1: LDH, PT \& activated partial thromboplastin time (aPTT)
* Cycle 4, 5, \& 6, and all subsequent cycles, Day 1: LDH

During the first cycle only patients will also need to come for a study visit on day 8 and 15. During these two visits, blood tests will be done again to check blood cell count and organ functions. Patients will also be asked how they are feeling and about any side effects that they may be having.

Computed tomography (CT) scans or a magnetic resonance imaging (MRI) will be done after every 2 cycles that each patient completes on the study. These will be done to help the doctor re-evaluate each patient's disease.

Patients may have some additional blood tests done if they are among the first 10 patients taking part in this study. In this case they will have 9 samples of blood (each about a teaspoonful) drawn from them at specifically timed intervals (at 30 minutes before the start and at 30 minutes, 2 hour 55 minutes, 3 hour 10 minutes, 3 hour 30 minutes, 5 hour, 8 hour, 27 hour (+/- 1 hour) and 168 hour (+/- 4 hours) after the start of the ZK-Epo infusion) so that we can better understand the level of this drug in the body and its metabolism in people.

Phase II Trial Of ZK-EPO (ZK 219477) (Sagopilone) In Metastatic Melanoma

Objective tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

PFS: the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD)according to modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

Median OS: the time (expressed in months or years) when half the patients are expected to be alive.

Number of participants with Grade 3 or higher adverse events, attributable to treatment with sagopilone.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases	NCT00496379	Breast Cancer CNS Disease	ZK219477	18 Years -	Dana-Farber Cancer Institute
ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases	NCT00496379	Breast Cancer CNS Disease	ZK219477	18 Years -	Dana-Farber Cancer Institute
Phase II Trial Of ZK-EPO (ZK 219477) (Sagopilone) In Metastatic Melanoma	NCT00598507	Melanoma	ZK-EPO	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for zk219477

Every month we try and update this database with for zk219477 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 zk219477

Every month we try and update this database with for zk219477 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 zk219477 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.