Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate of 20%

Outcome Description:

The 95% confidence intervals should be provided.

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Francis Giles

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02589

NCT ID:

NCT00084916

Start Date:

April 2004

Completion Date:

Related Keywords:

  • 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
  • Congenital Abnormalities
  • Anemia
  • Anemia, Refractory
  • Anemia, Refractory, with Excess of Blasts
  • Blast Crisis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Anemia, Aplastic

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030