Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid M… (NCT00776373) | Clinical Trial Compass
TerminatedPhase 1/2
Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid Malignancies
United States4 participantsStarted 2007-01
Plain-language summary
Assess the safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
* T…
What they're measuring
1
Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies