Nanoparticle Albumin-Bound Rapamycin in Treating Patients With Advanced Cancer With mTOR Mutations

Summary

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.

Conditions

• Advanced Malignant Neoplasm
• Cervical Squamous Cell Carcinoma
• Endometrial Carcinoma
• Malignant Uterine Neoplasm
• Recurrent Bladder Carcinoma
• Recurrent Breast Carcinoma
• Recurrent Cervical Carcinoma
• Recurrent Head and Neck Carcinoma
• Recurrent Malignant Neoplasm
• Recurrent Ovarian Carcinoma
• Recurrent Prostate Carcinoma
• Recurrent Renal Cell Carcinoma
• Solid Neoplasm
• Stage III Bladder Cancer
• Stage III Prostate Cancer
• Stage III Renal Cell Cancer
• Stage IIIA Breast Cancer
• Stage IIIA Cervical Cancer
• Stage IIIA Ovarian Cancer
• Stage IIIB Breast Cancer
• Stage IIIB Cervical Cancer
• Stage IIIB Ovarian Cancer
• Stage IIIC Breast Cancer
• Stage IIIC Ovarian Cancer
• Stage IV Breast Cancer
• Stage IV Ovarian Cancer
• Stage IV Prostate Cancer
• Stage IV Renal Cell Cancer
• Stage IVA Bladder Cancer
• Stage IVA Cervical Cancer
• Stage IVB Bladder Cancer
• Stage IVB Cervical Cancer

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Nanoparticle Albumin-Bound Rapamycin

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Mitesh Borad · Mayo Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2017-09-05

Completion

2018-04-24

Countries

• United States

Study Locations