Paraganglioma Clinical Trial
Official title:
Phase I Study of Anti-IGF-1R Monoclonal Antibody, IMC-A12, and mTOR Inhibitor, Everolimus, in Advanced Low to Intermediate Grade Neuroendocrine Carcinoma
This phase I trial studies the side effects and best dose of cixutumumab when given together with everolimus and octreotide acetate in treating patients with advanced low- or intermediate-grade neuroendocrine cancer. Monoclonal antibodies, such as cixutumumab, may find tumor cells and help carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide acetate may interfere with the growth of tumor cells and slow the growth of neuroendocrine cancer. Giving cixutumumab together with everolimus and octreotide acetate may be a better treatment for neuroendocrine cancer.
PRIMARY OBJECTIVES:
I. To recommend a phase 2 dose for the combination of IMC-A12 (cixutumumab) and everolimus,
given with octreotide long-acting release (LAR) (octreotide acetate), in patients with
advanced neuroendocrine tumors.
II. To describe the pharmacokinetics of IMC-A12 given once every 21 days in combination with
everolimus and octreotide LAR.
III. To evaluate pharmacodynamic markers in blood, and tumor tissue.
SECONDARY OBJECTIVES:
I. To evaluate the safety profile of IMC-A12 and everolimus with octreotide LAR.
II. To explore the anti-tumor activity of the combination of IMC-A12 and everolimus as
defined by Response Evaluation Criteria in Solid Tumors (RECIST) response rate and
progression-free survival (PFS).
TERTIARY OBJECTIVES:
I. To explore baseline molecular marker and drug-induced molecular marker changes that may
predict clinical outcome.
OUTLINE: This is a dose-escalation study of cixutumumab.
Patients receive cixutumumab intravenously (IV) over 60-90 minutes and octreotide acetate
intramuscularly (IM) on day 1 and everolimus orally (PO) once daily (QD) on days 1-21.
Treatment repeats every 21 days for up to 18 courses in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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