Rapamycin in Advanced Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00707135
Recruitment Status : Completed
First Posted : June 30, 2008
Last Update Posted : January 17, 2014
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The goal of this study is to determine the rapamycin dose equivalent to the recommended phase II/III dose of temsirolimus and determine the observed toxicities and anti-tumor response of rapamycin in patients with advanced cancers.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Rapamycin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Study of Rapamycin (Sirolimus) in Patients With Advanced Malignancies
Study Start Date : June 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Rapamycin
Rapamycin given once weekly in escalating doses. Higher dose levels will be split with the half the dose given on day 1 and half the dose on day 2 (24 hours later).
Other Names:
  • Rapamune
  • sirolimus

Primary Outcome Measures :
  1. Dose level equivalent to recommended phase 2/3 dose of temsirolimus [ Time Frame: 6 weeks ]
  2. observed toxicities [ Time Frame: 6 weeks ]
  3. anti-tumor effect [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 and CLL only) are eligible to participate in the phase Ib portion of the trial only. Patients must have relapsed or refractory disease that is no longer amenable to standard available therapy.
  • At least 4 weeks since prior chemotherapy or radiation therapy
  • Age >18 years
  • ECOG performance status less than or equal to 2
  • Life expectancy of greater than 3 months.
  • Normal organ and marrow function as defined below:

    • No transfusions of packed red blood cells with 1 week of starting treatment. An absolute level of hemoglobin does not constitute an eligibility criterion but patients should be transfused as clinically indicated.
    • Leukocytes ≥ 3,000/μL
    • WBC ≥ 1,500/μL for patients with hematologic malignancies
    • ANC ≥ 1,500/μL (≥1,000/μL for patients with hematologic malignancies)
    • Absolute lymphocyte count ≥ 1000/µL
    • CD4 count ≥ 500/μL
    • Platelets ≥ 100,000/μL (≥50,000/μL for patients with hematologic malignancies)
    • Total bilirubin within normal institutional limits
    • AST (SGOT) and ALT (SGPT) ≤ 2.5 times institutional upper limit of normal
    • Serum triglycerides ≤ 500 mg/dl
    • Creatinine within normal institutional limits OR
    • Creatinine clearance ≥ 60 mL/min/1.73 m2 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) prior to study entry and for the duration of study participation.
  • 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. 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. Patients with brain metastases or a malignant primary brain tumor must have stable neurologic status following local therapy (surgery or radiation) for at least 8 weeks from definitive therapy, and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients cannot be receiving enzyme inducing anti-convulsants.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, history of interstitial lung disease (including pneumonitis, bronchiolitis obliterans with organizing pneumonia, or pulmonary fibrosis) or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with severe immunodeficient states (as judged by the treating physician.
  • Pregnant women, breast-feeding must be stopped
  • HIV-positive patients are excluded due to possible pharmacokinetic interactions with rapamycin.
  • Concurrent use of ketoconazole, cyclosporine, tacrolimus, and rifampin with rapamycin is not permissible. Concurrent use of rapamycin with diltiazem is allowed but should be done with caution or avoided.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00707135

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Institutes of Health (NIH)

Responsible Party: University of Chicago Identifier: NCT00707135     History of Changes
Other Study ID Numbers: 13142A
First Posted: June 30, 2008    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs