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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.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00776373
First received: October 19, 2008
Last updated: September 29, 2010
Last verified: September 2010
History of Changes
  Purpose

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


Condition Intervention Phase
ALL
Burkitt's Lymphoma
Lymphoblastic Leukemia
CML
 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:

U.S. FDA Resources

Further study details as provided by 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 ]

Estimated Enrollment: 31
Study Start Date: January 2007
Estimated Study Completion Date: June 2010
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776373

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

No publications provided

Responsible Party: Selina Luger, M.D., University of Pennsylvania - Abramson Cancer Center
ClinicalTrials.gov Identifier: NCT00776373     History of Changes
Other Study ID Numbers: UPCC 25406
Study First Received: October 19, 2008
Last Updated: September 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
ALL
Burkitt's Lymphoma
Adult T-Cell leukemia/lymphoma
Lymphoblastic leukemia
 CML in lymphoid blast crisis patients
HiVAC
Rapamycin

Additional relevant MeSH terms:
Burkitt Lymphoma
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoma, B-Cell
Neoplasms, Experimental
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Sirolimus
Everolimus
Etoposide phosphate
Etoposide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013