Status:
TERMINATED
Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid Malignancies
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
ALL
Burkitt's Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Assess the safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00776373
Start Date
January 1 2007
End Date
December 1 2009
Last Update
November 5 2025
Active Locations (1)
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1
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19066