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

ALL Clinical Trial

— UPCC 25406  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00776373
• Other study ID #: UPCC 25406
• Status: Terminated
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• ALL
• Burkitt Lymphoma
• Burkitt's Lymphoma
• CML
• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Leukemia
• Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

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