Rapamycin With Grapefruit Juice for Adv… | Clinical Trial

Key information

Conditions

Tumors Adenoma Adnexal Diseases Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Male Urogenital Diseases Melanoma Mesothelioma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Thyroid Diseases Thyroid Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
Patients with hematologic malignancies (lymphoma, multiple myeloma and chronic lymphocytic leukemia (CLL) only) are eligible to participate in the phase IB portion of the trial only.
At least 4 weeks since prior chemotherapy or radiation therapy
Aged 18 years or older
ECOG performance status 0-2
Life expectancy of greater than 3 months.
Normal organ and marrow function:

No transfusions of packed red blood cells within 1 week of starting treatment
Leukocytes greater or equal to 3,000/μL

** White blood cell (WBC) greater or equal to 1,500/μL for patients with hematologic malignancies

Absolute neutrophil count (ANC) greater or equal to 1,500/μL

** ANC greater or equal to 1,000/μL for patients with hematologic malignancies

Platelets (PLT) greater or equal to 100,000/μL

** PLT greater or equal to 50,000/μL for patients with hematologic malignancies

Total bilirubin within normal institutional limits
AST (SGOT) and ALT (SGPT) less than or equal to 2.5 times institutional upper limit of normal
Serum triglycerides less than or equal to 500 mg/dl
Creatinine within normal institutional limits OR creatinine clearance greater or equal to 60 mL/min for patients with creatinine levels above institutional normal
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence)
Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
May not be receiving any other investigational agents.
Uncontrolled brain metastases or malignancy. Cannot be receiving enzyme-inducing anticonvulsants.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin
Gastrointestinal malabsorption syndromes, partial small bowel obstruction, or any illness that would interfere with the ability to absorb oral medications.
Uncontrolled intercurrent illness
Severe immunodeficient states (as judged by the treating physician)
Pregnant women are excluded from this study; breastfeeding should be discontinued.
HIV-positive patients receiving combination antiretroviral therapy are excluded.
Concurrent use of ketoconazole, cyclosporine, tacrolimus, diltiazem, and rifampin with rapamycin is not permissible. The concurrent use of calcium channel blockers, terfenadine, astemizole, cisapride, propafenone, cyclosporine, midazolam, triazolam, quinidine, or theophylline with grapefruit juice is not permissible.

Treatment and study plan

Rapamycin (sirolimus)

Drug

Weekly oral doses, dose is assigned at the time of study entry

Other names: Rapamune

Grapefruit Juice

Other

Daily oral doses starting during the second week on study.

Primary outcomes

Pharmacokinetic interaction

Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

A Phase Ib Study Administering Rapamycin (Sirolimus) With Grapefruit Juice in Patients With Advanced Malignancies

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2012
First posted: Sep 12, 2006
Registry last updated: Jan 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed