Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid Malignancies (UPCC 25406)

Abramson Cancer Center at Penn Medicine

Status and phase: Terminated; Phase 2; Phase 1

Conditions: CML; Lymphoblastic Leukemia; ALL; Burkitt's Lymphoma

Treatments: Drug: Rapamycin; Drug: High dose etoposide and cytarabine (HiVAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT00776373

UPCC 25406

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Arm 1

Experimental group

Description:

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

Treatment:

Drug: High dose etoposide and cytarabine (HiVAC)

Drug: Rapamycin