Clinical trial NCT00776373: Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid Malignancies
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: ALL
Burkitt's Lymphoma
Lymphoblastic Leukemia
CML
Keywords: ALL
Burkitt's Lymphoma
Adult T-Cell leukemia/lymphoma
Lymphoblastic leukemia
CML in lymphoid blast crisis patients
HiVAC
Rapamycin
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2008-10-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies
timeFrame: Study completion
Secondary outcomes:
measure: Assess and quantify phosphorylation of p70S6 kinase
timeFrame: Study completion
measure: Whether increased mTOR pathway inhibition correlates with response to therapy with rapamycin and HiVAC
timeFrame: Study completion
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Abramson Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania Abramson Cancer Center
name: Selina Luger, MD
role: PRINCIPAL_INVESTIGATOR
References: