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

NCT ID: NCT00776373

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-12-31

Brief Summary

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

Conditions

ALL; Burkitt's Lymphoma; Lymphoblastic Leukemia; CML

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Rapamycin in combination with High Dose Etoposide and Cytarabine (HiVAC)

Group Type: EXPERIMENTAL

Rapamycin

Intervention Type: DRUG

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

High dose etoposide and cytarabine (HiVAC)

Intervention Type: DRUG

Etoposide 500 mg/m2/day IV and Cytarabine 2000 mg/m2/day IV every 24 hours for 4 days.

Interventions

Rapamycin

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

Intervention Type: DRUG

High dose etoposide and cytarabine (HiVAC)

Etoposide 500 mg/m2/day IV and Cytarabine 2000 mg/m2/day IV every 24 hours for 4 days.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Selina Luger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania Abramson Cancer Center

Locations

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 25406

Identifier Type: -

Identifier Source: org_study_id