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

A Phase I/II, Open-label Single Institution Study Evaluating Rapamycin in Combination With High-dose Etoposide and Cytarabine in Relapsed or Refractory Aggressive Lymphoid Malignancies

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00776373

Acronym

UPCC 25406

Enrollment

Registered

2008-10-21

Start date

2007-01-31

Completion date

2009-12-31

Last updated

2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALL, Burkitt's Lymphoma, CML, Lymphoblastic Leukemia

Keywords

ALL, Burkitt's Lymphoma, Adult T-Cell leukemia/lymphoma, Lymphoblastic leukemia, CML in lymphoid blast crisis patients, HiVAC, Rapamycin

Brief summary

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

Interventions

DRUGRapamycin

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

DRUGHigh dose etoposide and cytarabine (HiVAC)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026