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A Phase Ib Study of Rapamycin (Sirolimus) in Patients With Advanced Malignancies

Phase 1
18 Years
Not Enrolling
Advanced Cancer

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Trial Information

A Phase Ib Study of Rapamycin (Sirolimus) in Patients With Advanced Malignancies

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

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose level equivalent to recommended phase 2/3 dose of temsirolimus

Outcome Time Frame:

6 weeks

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

June 2005

Completion Date:

December 2008

Related Keywords:

  • Advanced Cancer
  • Neoplasms



University of ChicagoChicago, Illinois  60637