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
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