Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid Malignancies

Phase 1

Terminated

• Conditions: Burkitt's Lymphoma; ALL; Lymphoblastic Leukemia; CML
• Interventions: Drug: Rapamycin + high dose etoposide and cytarabine

• Registration Number: NCT00776373
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-10-19
• Study First Submitted QC: 2008-10-20
• Study First Posted: 2008-10-21
• Primary Completion: 2008-12
• Study Completion: 2009-12
• Status Verified: 2020-04
• Disposition First Submitted: 2020-04-15
• Disposition First Submitted QC: 2020-04-15
• Last Update Submitted: 2020-04-15
• Disposition First Posted: 2020-04-21
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Rapamycin + high dose etoposide and cytarabine	Rapamycin in combination with High Dose Etoposide and Cytarabine (HiVAC)

Primary Outcome Measures

Name	Time	Method
Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies	Study completion

Secondary Outcome Measures

Name	Time	Method
Whether increased mTOR pathway inhibition correlates with response to therapy with rapamycin and HiVAC	Study completion
Assess and quantify phosphorylation of p70S6 kinase	Study completion

Trial Locations

Locations (1)

University of Pennsylvania Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States