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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00776373
Other study ID # UPCC 25406
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date January 2007
Est. completion date December 2009

Study information

Verified date April 2020
Source Abramson Cancer Center of the University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date December 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Pennsylvania Abramson Cancer Center Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies Study completion
Secondary Assess and quantify phosphorylation of p70S6 kinase Study completion
Secondary Whether increased mTOR pathway inhibition correlates with response to therapy with rapamycin and HiVAC Study completion
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