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Rapamycin With Grapefruit Juice for Advanced Malignancies
This study is ongoing, but not recruiting participants.
Study NCT00375245   Information provided by University of Chicago
First Received: September 11, 2006   Last Updated: February 12, 2009   History of Changes

September 11, 2006
February 12, 2009
September 2006
November 2009   (final data collection date for primary outcome measure)
Pharmacokinetic interaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Maximum tolerated dose, observed toxicities, dose limiting toxicities, and anti-tumor response of weekly rapamycin (sirolimus) in combination with grapefruit juice
Complete list of historical versions of study NCT00375245 on ClinicalTrials.gov Archive Site
 
  • Define the pharmacokinetics of once weekly rapamycin and grapefruit juice
  • Determine the relationship between a weekly oral dose of rapamycin, whole blood
  • rapamycin levels, and p70S6 kinase (S6K) phosphorylation in peripheral blood Tcells
  • (PBL)
  • Model a dose-effect relationship between rapamycin dose and inhibition of S6K
  • phosphorylation
 
Rapamycin With Grapefruit Juice for Advanced Malignancies
A Phase Ib Study Administering Rapamycin (Sirolimus) With Grapefruit Juice in Patients With Advanced Malignancies

The purpose of this study is to determine the highest safe dose of rapamycin when given with a fixed amount of grapefruit juice.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
  • Tumors
  • Neoplasm Metastasis
  • Drug: Rapamycin (sirolimus)
  • Other: Grapefruit Juice
 
Treiber G. mTOR inhibitors for hepatocellular cancer: a forward-moving target. Expert Rev Anticancer Ther. 2009 Feb;9(2):247-61.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
64
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00375245
Ezra Cohen, MD, University of Chicago
14435B
University of Chicago
 
Principal Investigator: Ezra W Cohen, MD University of Chicago
University of Chicago
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP