UPCC 25406: Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid Malignancies
Study Details
Study Description
Brief Summary
Assess the safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Arm 1 Rapamycin in combination with High Dose Etoposide and Cytarabine (HiVAC) |
Drug: Rapamycin + high dose etoposide and cytarabine
Rapamycin,by mouth, loading dose followed by a single daily dose for 8 days (dose level 1 = load of 9 mg followed by 3 mg daily doses, dose level 2 = 12 mg with daily doses of 4 mg; Etoposide 500 mg/m2/day IV and Cytarabine 2000 mg/m2/day IV every 24 hours for 4 days.
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Outcome Measures
Primary Outcome Measures
- Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies [Study completion]
Secondary Outcome Measures
- Assess and quantify phosphorylation of p70S6 kinase [Study completion]
- Whether increased mTOR pathway inhibition correlates with response to therapy with rapamycin and HiVAC [Study completion]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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= 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:
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Subjects must not be receiving any chemotherapy agents (except Hydroxyurea)
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Subjects must not have received high-dose Ara-C within 6 months of relapse
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Subjects must not be receiving growth factors, except for erythropoietin
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No currently active second malignancy other than non-melanoma skin cancers
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No subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, MI within the last 6 months or serious uncontrolled cardiac arrhythmia
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Subjects taking Carbamazepine, Rifabutin, Rifampin, Rifapentine, St. John's wort, Clarithromycin, Cyclosporine, Diltiazem, Erythromycin, Telithromycin, Verapamil, Tacrolimus
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Known HIV positivity or AIDS-related illness
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Evidence of cerebellar dysfunction or prior history of cerebellar dysfunction with Ara-C administration
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Pregnant or lactating
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Uncontrolled infection
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Taking fluconazole, voriconazole, itraconazole and ketoconazole currently or within one week of study entry
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania | United States | 19066 |
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
Investigators
- Principal Investigator: Selina Luger, MD, University of Pennsylvania Abramson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UPCC 25406