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

Phase 1
18 Years
Not Enrolling
Advanced Cancer

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Trial Information

A Phase Ib Study Administering Rapamycin (Sirolimus) With Ketoconazole 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, multiple myeloma and 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 (6 weeks if the last
regimen included BCNU or mitomycin C).

- Age >18 years.

- ECOG performance status less than or equal to 2

- Life expectancy of more than 3 months.

- Normal organ and marrow function as defined below:

- Hemoglobin ≥ 10 g/dl

- Leukocytes ≥ 3,000/µL

o WBC ≥ 1,500/µL for patients with hematologic malignancies

- Absolute neutrophil count ≥ 1,500/µL (≥ 1,000/µL for patients with hematologic

- Absolute lymphocyte count ≥1000/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 ULN

- 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.

- Able to understand and the willing 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 not recovered from adverse events due to agents
administered more than 4 weeks earlier.

- Receiving any other investigational agents.

- Uncontrolled brain metastases or malignancy.

- 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, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Severe immunodeficient state (as judged by the treating physician)

- Pregnancy (breast-feeding must be discontinued)

- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study because of possible pharmacokinetic interactions with rapamycin.

- Concurrent use of cyclosporine, tacrolimus, and rifampin, terfenadine, astemizole,
cisapride, rosiglitazone or pioglitazone due to possible interactions with the study
drugs. Ketoconazole cannot be taken within 2 hours of an antacid.

Type of Study:


Study Design:

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

Outcome Measure:

maximum tolerated dose

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Ezra Cohen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Institutional Review Board

Study ID:




Start Date:

October 2004

Completion Date:

December 2008

Related Keywords:

  • Advanced Cancer
  • Neoplasms



University of Chicago Chicago, Illinois  60637