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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

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