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CCI-779 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Chronic Myelogenous Leukemia in Blastic Phase

Primary Purpose

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temsirolimus
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of 1 of the following: Acute myeloid leukemia Acute lymphoblastic leukemia Myelodysplastic syndromes Refractory anemia with excess blasts [RAEB] RAEB in transformation Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood/bone marrow blasts Chronic myelogenous leukemia in blastic phase Disease status must meet 1 of the following criteria: Primary resistant disease (i.e., failed to achieve a complete response [CR] to a prior standard induction regimen) Relapsed disease after achieving a CR Documented failure to most recent cytotoxic regimen No other potentially curative options No known CNS disease Performance status - ECOG 0-2 SGOT or SGPT < 3 times upper limit of normal* Bilirubin ≤ 2 mg/dL* Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement) No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reaction attributed to compounds of similar chemical or biological composition to CCI-779 No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No AIDS-defining disease HIV positive allowed if CD4 counts normal No other concurrent uncontrolled illness No concurrent prophylactic hematopoietic colony-stimulating factors More than 2 weeks since prior cytotoxic chemotherapy (except hydroxyurea) and recovered More than 2 weeks since prior radiotherapy and recovered No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer agents or therapies

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (temsirolimus)

Arm Description

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Response rate of 20%
The 95% confidence intervals should be provided.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2004
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00084916
Brief Title
CCI-779 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Chronic Myelogenous Leukemia in Blastic Phase
Official Title
A Phase II Study Of CCI-779 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Or Chronic Myeloid Leukemia In Blastic-Phase
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia in blastic phase
Detailed Description
PRIMARY OBJECTIVES: I. Determine the activity of CCI-779 in patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, or chronic myelogenous leukemia in blastic phase. II. Correlate the effect of this drug with altered mitochondrial respiration in the leukemia cells of these patients. OUTLINE: Patients are stratified according to disease (acute myeloid leukemia, myelodysplastic syndromes, chronic myelogenous leukemia in blastic phase [CML-BP] non-lymphoid vs acute lymphoblastic leukemia, CML-BP lymphoid). Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this study within 8-46 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Excess Blasts in Transformation, Relapsing Chronic Myelogenous Leukemia, Secondary Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (temsirolimus)
Arm Type
Experimental
Arm Description
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
temsirolimus
Other Intervention Name(s)
CCI-779, cell cycle inhibitor 779, Torisel
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate of 20%
Description
The 95% confidence intervals should be provided.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of 1 of the following: Acute myeloid leukemia Acute lymphoblastic leukemia Myelodysplastic syndromes Refractory anemia with excess blasts [RAEB] RAEB in transformation Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood/bone marrow blasts Chronic myelogenous leukemia in blastic phase Disease status must meet 1 of the following criteria: Primary resistant disease (i.e., failed to achieve a complete response [CR] to a prior standard induction regimen) Relapsed disease after achieving a CR Documented failure to most recent cytotoxic regimen No other potentially curative options No known CNS disease Performance status - ECOG 0-2 SGOT or SGPT < 3 times upper limit of normal* Bilirubin ≤ 2 mg/dL* Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement) No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reaction attributed to compounds of similar chemical or biological composition to CCI-779 No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No AIDS-defining disease HIV positive allowed if CD4 counts normal No other concurrent uncontrolled illness No concurrent prophylactic hematopoietic colony-stimulating factors More than 2 weeks since prior cytotoxic chemotherapy (except hydroxyurea) and recovered More than 2 weeks since prior radiotherapy and recovered No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer agents or therapies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis Giles
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

CCI-779 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Chronic Myelogenous Leukemia in Blastic Phase

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