Stage IV Breast Cancer Clinical Trial
Official title:
A Pilot Study of a Rapid Access Platform for Investigational Drugs (RAPID) in Advanced Cancers
This pilot trial studies how well nanoparticle albumin-bound rapamycin works in treating patients with cancer that as has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced cancer) and that has an abnormality in a protein called mechanistic target of rapamycin (mTOR). Patients with this mutation are identified by genetic testing. Patients then receive nanoparticle albumin-bound rapamycin, which may stop the growth of cancer cells by blocking the mTOR enzyme, which is needed for cell growth and multiplication. Using treatments that target a patient's specific mutation may be a more effective treatment than the standard of care treatment.
PRIMARY OBJECTIVES:
I. To investigate efficacy of groups of patients defined by disease type, genomic aberration
and treatment regimen.
II. To assess the confirmed response rate of nanoparticle albumin-bound rapamycin
(nab-rapamycin) in mTOR aberrant advanced cancers. (Sub-protocol Arm A)
SECONDARY OBJECTIVES:
I. To estimate other clinical outcomes (e.g., progression-free and overall survival) of
groups of patients defined by disease type, genomic aberration and treatment regimen.
II. To describe the adverse event profile of each regimen. III. To assess the clinical
benefit rate of nab-rapamycin in mTOR aberrant advanced cancers. (Sub-protocol Arm A).
IV. To estimate progression-free survival (specifically at 6 months) and overall survival of
these patients. (Sub-protocol Arm A) V. To estimate the adverse event profile of
nab-rapamycin. (Sub-protocol Arm A)
TERTIARY OBJECTIVES:
I. To describe patient health-related quality of life (HRQOL) and symptoms using the European
Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core
(QLQ-C)30 in groups of patients defined by disease type and/or treatment regimen and to
correlative HRQOL/symptoms with genomic markers.
II. To assess the rate of individual mTOR pathway aberrations and assess the association
between individual mTOR pathway aberrations and clinical outcome both across disease
indications and within disease indications. (Sub-protocol Arm A)
OUTLINE:
Patients receive nanoparticle albumin-bound rapamycin intravenously (IV) over 30 minutes on
days 1 and 8. Treatment repeats every 21 days for 24 weeks in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
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