ALL Clinical Trial
— UPCC 25406Official 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
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 |
Assess the safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center of the University of Pennsylvania |
United States,
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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