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

This study has been terminated.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania Identifier:
First received: October 19, 2008
Last updated: June 7, 2016
Last verified: June 2016
Assess the safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies.

Condition Intervention Phase
Burkitt's Lymphoma
Lymphoblastic Leukemia
Drug: Rapamycin + high dose etoposide and cytarabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess and quantify phosphorylation of p70S6 kinase [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]
  • Whether increased mTOR pathway inhibition correlates with response to therapy with rapamycin and HiVAC [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: January 2007
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Rapamycin in combination with High Dose Etoposide and Cytarabine (HiVAC)
Drug: Rapamycin + high dose etoposide and cytarabine
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; Etoposide 500 mg/m2/day IV and Cytarabine 2000 mg/m2/day IV every 24 hours for 4 days.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00776373

United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19066
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Principal Investigator: Selina Luger, MD University of Pennsylvania Abramson Cancer Center
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT00776373     History of Changes
Other Study ID Numbers: UPCC 25406 
Study First Received: October 19, 2008
Last Updated: June 7, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Burkitt's Lymphoma
Adult T-Cell leukemia/lymphoma
Lymphoblastic leukemia
CML in lymphoid blast crisis patients

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Burkitt Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic processed this record on October 21, 2016