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Carboplatin and ABI-007 in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

2014-08-27 03:41:25 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin together with ABI-007 works in treating patients with stage IV melanoma that cannot be removed by surgery.

Description

OBJECTIVES:

Primary

- Assess the safety and antitumor activity of carboplatin and paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) in patients with unresectable stage IV melanoma who have not received prior chemotherapy for their metastatic disease. (Cohort 1)

- Assess the safety and antitumor activity of this regimen in patients with unresectable stage IV melanoma who have received prior chemotherapy for their metastatic disease. (Cohort 2)

Secondary

- Describe the impact of this regimen on parameters of immune function and angiogenesis in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy for metastatic disease (yes vs no).

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic and rich in cysteine (SPARC) content of tumor tissue by immunohistochemistry and to explore the impact of therapy on immune homeostasis. Samples are also analyzed by immunoenzyme techniques for angiogenesis markers.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Melanoma (Skin)

Intervention

carboplatin, paclitaxel albumin-stabilized nanoparticle formulation, protein expression analysis, immunoenzyme technique, immunohistochemistry staining method, laboratory biomarker analysis, biopsy

Location

Mayo Clinic Scottsdale
Scottsdale
Arizona
United States
85259-5499

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:41:25-0400

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Medical and Biotech [MESH] Definitions

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

A condition in which albumin level in blood (SERUM ALBUMIN) is below the normal range. Hypoalbuminemia may be due to decreased hepatic albumin synthesis, increased albumin catabolism, altered albumin distribution, or albumin loss through the urine (ALBUMINURIA).

An organoplatinum compound that possesses antineoplastic activity.

Cell surface proteins that bind albumin with high affinity and trigger intracellular changes influencing the behavior of cells.

Serum albumin from cows, commonly used in in vitro biological studies. (From Stedman, 25th ed)

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