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

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Terminated
CT.gov ID
NCT00776373
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Rapamycin + high dose etoposide and cytarabine
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
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
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies [Study completion]

Secondary Outcome Measures

  1. Assess and quantify phosphorylation of p70S6 kinase [Study completion]

  2. Whether increased mTOR pathway inhibition correlates with response to therapy with rapamycin and HiVAC [Study completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00776373
Other Study ID Numbers:
  • UPCC 25406
First Posted:
Oct 21, 2008
Last Update Posted:
Apr 21, 2020
Last Verified:
Apr 1, 2020

Study Results

No Results Posted as of Apr 21, 2020