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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:
ClinicalTrials.gov Identifier:
NCT00776373
First Posted: October 21, 2008
Last Update Posted: June 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776373


Locations
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
Investigators
Principal Investigator: Selina Luger, MD University of Pennsylvania Abramson Cancer Center
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00776373     History of Changes
Other Study ID Numbers: UPCC 25406
First Submitted: October 19, 2008
First Posted: October 21, 2008
Last Update Posted: June 8, 2016
Last Verified: June 2016

Keywords provided by Abramson Cancer Center of the 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:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Burkitt Lymphoma
Neoplasms by Histologic Type
Neoplasms
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
Lymphoma
Etoposide
Etoposide phosphate
Cytarabine
Sirolimus
Everolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic