Rapamycin With Grapefruit Juice for Advanced Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00375245
First received: September 11, 2006
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Tumors
Neoplasm Metastasis
Drug: Rapamycin (sirolimus)
Other: Grapefruit Juice
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib Study Administering Rapamycin (Sirolimus) With Grapefruit Juice in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Pharmacokinetic interaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: September 2006
Study Completion Date: May 2012
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rapamycin + Grapefruit juice Drug: Rapamycin (sirolimus)
Weekly oral doses, dose is assigned at the time of study entry
Other Name: Rapamune
Other: Grapefruit Juice
Daily oral doses starting during the second week on study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375245

Locations
United States, Illinois
University of Chicago Hospitals
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Ezra W Cohen, MD University of Chicago
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00375245     History of Changes
Other Study ID Numbers: 14435B
Study First Received: September 11, 2006
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
phase I
metastatic
advanced cancer
lung cancer
renal cancer
kidney cancer
head and neck cancer
bladder cancer
breast cancer
colorectal cancer
esophagus
GIST
liver cancer
melanoma
mesothelioma
lymphoma
ovary cancer
ovarian cancer
pancreas cancer
pancreatic cancer
prostate cancer
stomach cancer
thyroid cancer
Metastatic solid tumor

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014