NCT00776373

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

October 19, 2008

Last Update Submit

November 2, 2025

Conditions

ALLBurkitt's LymphomaLymphoblastic LeukemiaCML

Keywords

ALLBurkitt's LymphomaAdult T-Cell leukemia/lymphomaLymphoblastic leukemiaCML in lymphoid blast crisis patientsHiVACRapamycin

Outcome Measures

Primary Outcomes (1)

  • Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies

    Study completion

Secondary Outcomes (2)

  • 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

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Drug: RapamycinDrug: High dose etoposide and cytarabine (HiVAC)

Interventions

RapamycinDRUG

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

Arm 1
High dose etoposide and cytarabine (HiVAC)DRUG

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

Arm 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19066, United States

Location

MeSH Terms

Conditions

Burkitt LymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

SirolimusEtoposideCytarabine

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Selina Luger, MD

    University of Pennsylvania Abramson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2008

First Posted

October 21, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

November 5, 2025

Record last verified: 2025-11

Locations

US(1)