Expired Study
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Chicago, Illinois 60637


Purpose:

To determine the maximum tolerated dose, observed toxicities, and dose limiting toxicities, and antitumor response of rapamycin plus ketoconazole in patients with advanced cancers.


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 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 malignancies) - 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.


NCT ID:

NCT00708591


Primary Contact:

Principal Investigator
Ezra Cohen, MD
University of Chicago


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60637
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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