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Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid Malignancies (UPCC 25406)

Primary Purpose

ALL, Burkitt's Lymphoma, Lymphoblastic Leukemia

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Rapamycin + high dose etoposide and cytarabine

About this trial

This is an interventional treatment trial for ALL focused on measuring ALL, Burkitt's Lymphoma, Adult T-Cell leukemia/lymphoma, Lymphoblastic leukemia, CML in lymphoid blast crisis patients, HiVAC, Rapamycin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Pennsylvania Abramson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Rapamycin in combination with High Dose Etoposide and Cytarabine (HiVAC)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assess and quantify phosphorylation of p70S6 kinase

Whether increased mTOR pathway inhibition correlates with response to therapy with rapamycin and HiVAC

Full Information

NCT ID

NCT00776373

First Posted

October 19, 2008

Last Updated

April 15, 2020

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00776373

Brief Title

Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid Malignancies

Acronym

UPCC 25406

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

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Terminated

Study Start Date

January 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Rapamycin in combination with High Dose Etoposide and Cytarabine (HiVAC)

Intervention Type

Drug

Intervention Name(s)

Rapamycin + high dose etoposide and cytarabine

Intervention Description

Rapamycin,by mouth, loading dose followed by a single daily dose for 8 days (dose level 1 = load of 9 mg followed by 3 mg daily doses, dose level 2 = 12 mg with daily doses of 4 mg; Etoposide 500 mg/m2/day IV and Cytarabine 2000 mg/m2/day IV every 24 hours for 4 days.

Primary Outcome Measure Information:

Title

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

Time Frame

Study completion

Secondary Outcome Measure Information:

Title

Assess and quantify phosphorylation of p70S6 kinase

Time Frame

Study completion

Title

Whether increased mTOR pathway inhibition correlates with response to therapy with rapamycin and HiVAC

Time Frame

Study completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Selina Luger, MD

Organizational Affiliation

University of Pennsylvania Abramson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania Abramson Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19066

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid Malignancies

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