Expired Study
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Philadelphia, Pennsylvania 19066


Purpose:

Assess the safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies.


Criteria:

Inclusion Criteria: - Advanced lymphoid leukemia (primary refractory ALL; Relapsed ALL; CML in lymphoid accelerated phase or blast crisis; relapsed or refractory Burkitt's lymphoma; relapsed or refractory T-cell adult leukemia/lymphoma; relapsed or refractory lymphoblastic lymphoma - >= 18 and <= 65 years of age ECOG performance status 0, 1 Life expectancy >= 4 weeks Able to consume oral medication Required initial laboratory values: Creatinine <= 2.0mg/dL, total or direct bilirubin <= 1.5 mg/dL, SGPT(ALT) <=ULN, glucose < 200 mg/dL, negative pregnancy test for women with child bearing potential Exclusion Criteria: - Subjects must not be receiving any chemotherapy agents (except Hydroxyurea) - Subjects must not have received high-dose Ara-C within 6 months of relapse - Subjects must not be receiving growth factors, except for erythropoietin - No currently active second malignancy other than non-melanoma skin cancers - No subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, MI within the last 6 months or serious uncontrolled cardiac arrhythmia - Subjects taking Carbamazepine, Rifabutin, Rifampin, Rifapentine, St. John's wort, Clarithromycin, Cyclosporine, Diltiazem, Erythromycin, Telithromycin, Verapamil, Tacrolimus - Known HIV positivity or AIDS-related illness - Evidence of cerebellar dysfunction or prior history of cerebellar dysfunction with Ara-C administration - Pregnant or lactating - Uncontrolled infection - Taking fluconazole, voriconazole, itraconazole and ketoconazole currently or within one week of study entry


NCT ID:

NCT00776373


Primary Contact:

Principal Investigator
Selina Luger, MD
University of Pennsylvania Abramson Cancer Center


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19066
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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