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Immunotoxin Therapy, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer

2014-08-27 03:16:58 | BioPortfolio

Summary

RATIONALE: Immunotoxins can find certain tumor cells and kill them without harming normal cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving immunotoxin therapy together with paclitaxel, carboplatin, and bevacizumab may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of immunotoxin when given together with paclitaxel, carboplatin, and bevacizumab in treating patients with advanced non-small cell lung cancer.

Description

OBJECTIVES:

Primary

- To determine a safe and tolerable dose of SS1(dsFv)-PE38 immunotoxin in combination with paclitaxel, carboplatin, and bevacizumab in patients with advanced mesothelin-expressing non-small cell lung adenocarcinoma.

Secondary

- To assess the duration of response and progression-free survival of patients treated with this regimen.

- To characterize the pharmacokinetics of this regimen in these patients.

- To monitor serum mesothelin levels before and during chemotherapy.

- To identify T-cell epitopes responsible for neutralizing SS1(dsFv)-PE38 immunotoxin activity using mononuclear cells obtained by apheresis.

OUTLINE: This is a dose-escalation study of SS1(dsFv)-PE38 immunotoxin.

Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive SS1(dsFv)-PE38 immunotoxin IV over 30 minutes on days 2, 4, and 6 of courses 1 and 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients then receive bevacizumab alone every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically for pharmacokinetic studies and measurement of circulating serum mesothelin levels.

After completion of study treatment, patients are followed up every 2-3 months for up to 2 years.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

SS1(dsFv)-PE38 immunotoxin, bevacizumab, carboplatin, paclitaxel, laboratory biomarker analysis, pharmacological study

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda
Maryland
United States
20892-1182

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:58-0400

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