Track topics on Twitter Track topics that are important to you
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.
- 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.
- 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.
Masking: Open Label, Primary Purpose: Treatment
SS1(dsFv)-PE38 immunotoxin, bevacizumab, carboplatin, paclitaxel, laboratory biomarker analysis, pharmacological study
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:16:58-0400
Background: - Advanced cases of non-small-cell lung carcinoma (NSCLC) usually are not successfully treated with standard therapies. Even treatments that attempt to specifically ta...
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating advanced solid tumors. PURPOSE: This phase I tr...
Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
This randomized phase II trial studies paclitaxel, carboplatin, and bevacizumab or paclitaxel, carboplatin, and temsirolimus or ixabepilone, carboplatin, and bevacizumab to see how well th...
RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment for non-small cell lung cancer may help doctors predict how patients will respond to treatment. ...
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by k...
The carboplatin/paclitaxel doublet remains the chemotherapy backbone for the initial treatment of ovarian cancer. This two-drug regimen, with carboplatin dosed using the Calvert formula, yielded convi...
Phase III trials have shown improved survival in ovarian cancer patients when the anti-vascular endothelial growth factor (VEGF) therapy bevacizumab is added to first-line chemotherapy. However, furth...
Angiotensin receptor blockers (ARBs) are often used in patients on paclitaxel (PTX) and carboplatin combination (TC) therapy to treat hypertension caused by the co-administration of bevacizumab. The a...
Background The cancer-cell-killing property of atezolizumab may be enhanced by the blockade of vascular endothelial growth factor-mediated immunosuppression with bevacizumab. This open-label, phase 3 ...
Nanoparticle albumin-bound paclitaxel (nab-paclitaxel), a microtubule inhibitor, has demonstrated clinical efficacy in the treatment of advanced non-small cell lung cancer (NSCLC) either as monotherap...
An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.
An organoplatinum compound that possesses antineoplastic activity.
Organized services provided by MEDICAL LABORATORY PERSONNEL for the purpose of carrying out CLINICAL LABORATORY TECHNIQUES used for the diagnosis, treatment, and prevention of disease.
An anti-VEGF recombinant monoclonal antibody consisting of humanized murine antibody. It inhibits VEGF receptors and prevents the proliferation of blood vessels.
Works containing concise background information and directions for activities, including conducting experiments or diagnostic tests in the laboratory.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
GILOTRIF (afatinib) is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L8...