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

NCT ID: NCT00084916

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (temsirolimus)

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.

Group Type: EXPERIMENTAL

temsirolimus

Intervention Type: DRUG

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

temsirolimus

Given IV

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

CCI-779; cell cycle inhibitor 779; Torisel

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis Giles

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MDA-2003-0830

Identifier Type: -

Identifier Source: secondary_id

N01CM62202

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000367093

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02589

Identifier Type: -

Identifier Source: org_study_id