Status:
COMPLETED
CCI-779 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Chronic Myelogenous Leukemia in Blastic Phase
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pat...
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 myelogenou...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00084916
Start Date
April 1 2004
Last Update
January 23 2013
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030