Topics

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

2014-08-27 03:33:34 | BioPortfolio

Summary

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.

Description

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 LDH to check organ function. PT and an aPTT to see if the patient's blood clots normally. EKG- Electrocardiogram (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 & 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.

CT scans or an 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Melanoma

Intervention

EpothiloneZK

Location

H. Lee Moffitt Cancer Center & Research Institute
Tampa
Florida
United States
33612

Status

Active, not recruiting

Source

H. Lee Moffitt Cancer Center and Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:33:34-0400

Clinical Trials [1099 Associated Clinical Trials listed on BioPortfolio]

Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine...

Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns

The purpose of this study is to examine the health behaviors of melanoma survivors. We want to know about their thoughts and concerns. Melanoma is a type of skin cancer. The number of peop...

The Impact of Melanoma and Drug Treatment in the Real World

An observational, non-interventional registry study to collect real-world data from people living with melanoma and its treatment, which will be available to researchers to further the kno...

Vaccination Plus Ontak in Patients With Metastatic Melanoma

The purpose of this study is to determine if an experimental melanoma vaccine can produce an immune response in patients with metastatic melanoma, and if combining this vaccine with the d...

Phase I/II Study of Chemo-Immunotherapy Combination in Melanoma Patients

This phase I/II study is directed at evaluating safety and immunogenicity of a melanoma peptide vaccine in combination or not with Dacarbazine administration in melanoma patients

PubMed Articles [883 Associated PubMed Articles listed on BioPortfolio]

Genetic Alterations in Primary Melanoma in Taiwan.

Acral melanoma (AM) is the most common histopathological subtype of malignant melanoma in Asians. However, differences in the mutational profiles underlying AM and non-acral cutaneous melanoma (NAM) i...

Management of invasive melanoma.

Maximising survival for patients with invasive melanoma hinges on early diagnosis of primary melanoma and appropriate management. Despite well-documented guidelines, many patients with melanoma have n...

Neoadjuvant PD-1 Blockade in Resectable Lung Cancer; Nivolumab and Ipilimumab in Advanced Melanoma; Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma; Prolonged Survival in Stage III Melanoma with Ipilimumab Adjuvant Therapy; Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma; Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma; Niv

Incidence trends of conjunctival malignant melanoma in Canada.

Melanoma is the most common primary malignancy of the eye in adults. While the epidemiology of uveal melanoma has recently been described in Canada, little is known about the epidemiology and geograph...

No Evidence for Role of Cutavirus in Malignant Melanoma.

Cutavirus was previously found in cutaneous melanoma. We detected cutavirus DNA in only 2/185 melanoma biopsies and in 0/52 melanoma metastases from patients in Germany. Viral DNA was localized in the...

Medical and Biotech [MESH] Definitions

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

Found in large amounts in the plasma and urine of patients with malignant melanoma. It is therefore used in the diagnosis of melanoma and for the detection of postoperative metastases. Cysteinyldopa is believed to be formed by the rapid enzymatic hydrolysis of 5-S-glutathionedopa found in melanin-producing cells.

A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.

More From BioPortfolio on "Phase II Trial Of ZK-EPO (ZK 219477) In Metastatic Melanoma"

Quick Search

Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...


Searches Linking to this Trial