Rapamycin With Grapefruit Juice For Advanced Malignancies

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-09-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-01-16
First Submitted that Met QC Criteria 2006-09-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-01-17
First Posted (ESTIMATED) 2006-09-12	Results First Posted N/A	Last Verified 2014-01

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Rapamycin + Grapefruit juice	DRUG: Rapamycin (sirolimus) Weekly oral doses, dose is assigned at the time of study entry OTHER: Grapefruit Juice Daily oral doses starting during the second week on study.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Rapamycin + Grapefruit juice

DRUG: Rapamycin (sirolimus)

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

OTHER: Grapefruit Juice

Daily oral doses starting during the second week on study.

Primary Outcome Measures	Measure Description	Time Frame
Pharmacokinetic interaction		4 weeks

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

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