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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


Phase 1/Phase 2
18 Years
65 Years
Not Enrolling
Both
ALL, Burkitt's Lymphoma, Lymphoblastic Leukemia, CML

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies

Outcome Time Frame:

Study completion

Safety Issue:

Yes

Principal Investigator

Selina Luger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania Abramson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UPCC 25406

NCT ID:

NCT00776373

Start Date:

January 2007

Completion Date:

June 2010

Related Keywords:

  • ALL
  • Burkitt's Lymphoma
  • Lymphoblastic Leukemia
  • CML
  • ALL
  • Burkitt's Lymphoma
  • Adult T-Cell leukemia/lymphoma
  • Lymphoblastic leukemia
  • CML in lymphoid blast crisis patients
  • HiVAC
  • Rapamycin
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma

Name

Location

University of Pennsylvania Abramson Cancer CenterPhiladelphia, Pennsylvania  19104