Status:
COMPLETED
7-Hydroxystaurosporine and Perifosine in Treating Patients With Relapsed or Refractory Acute Leukemia, Chronic Myelogenous Leukemia or High Risk Myelodysplastic Syndromes
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of 7-hydroxystaurosporine when given together with perifosine in treating patients with relapsed or refractory acute leukemia, chronic mye...
Detailed Description
PRIMARY OBJECTIVES: I. Define the maximum tolerated dose and recommended phase II dose of UCN-01 (7-hydroxystaurosporine) administered after perifosine in patients with relapsed or refractory acute l...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed hematologic malignancy of 1 of the following types:
- Relapsed or refractory acute myelogenous leukemia (AML)
- Patients with acute promyelocytic leukemia t(15;17) are eligible provided they failed a prior tretinoin and arsenic-containing regimen
- Patients should be either refractory to both agents (absence of durable hematologic response) OR relapsed after a complete response duration of \< 6 months
- Relapsed or refractory pre-B-cell or T-cell acute lymphoblastic leukemia (ALL)
- Chronic myelogenous leukemia (CML) in accelerated or blastic phase that is refractory to imatinib mesylate
- Must have evidence of disease progression despite continued treatment with imatinib mesylate
- AML arising in the setting of underlying myelodysplastic syndromes (MDS) and/or myeloproliferative disorders (MPD)
- Secondary or therapy-related AML
- De novo AML or pre-B-cell or T-cell ALL in adults \> 60 years of age with poor-risk features, such as complex (≥ 3) or adverse cytogenetics
- The following are considered adverse cytogenetic abnormalities for AML:
- -5q
- 7q-
- 9q-
- 20q-
- abn12p
- +21
- +8
- t(6;9)
- t(6;11)
- t(11;19)
- -7
- -5
- inv3/t(3;3)
- abn11q23
- abn17p
- abn21q
- t(9;22) refractory to imatinib mesylate
- The following are considered adverse cytogenetic abnormalities for ALL:
- t(9;22) refractory to imatinib mesylate
- Hypodiploidy
- t(4;11)
- t(1;19)
- Myelodysplastic Syndromes (MDS) meeting 1 of the following criteria:
- Intermediate and high risk (i.e., International Prognostic Scoring System \[IPSS\] ≥ 1.5) MDS that is refractory or has progressed after treatment with azacitidine and/or decitabine
- Intermediate and high risk (i.e., IPSS ≥ 1.5) MDS with a 5q- cytogenetic abnormality that is refractory or has progressed after treatment with lenalidomide, azacitidine, or decitabine
- Intermediate 2 and high risk MDS without 5q- cytogenetic abnormality that is refractory or has progressed after azacitidine or decitabine
- Original 5q must also be refractory to lenalidomide
- Received OR ineligible for established curative regimens, including stem cell transplantation
- No active CNS leukemia
- ECOG performance status (PS) 0-2 OR Karnofsky PS ≥ 60%
- Total or direct bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST/ALT ≤ 2.5 times ULN
- Creatinine ≤ 2 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No hyperleukocytosis (i.e., WBC \> 30,000/mm\^3) (recent treatment with hydroxyurea to prevent impending leukostasis allowed provided there has been no dose increase for ≥ 1 week)
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to UCN-01 or perifosine
- No intrinsic impaired organ function
- No active, uncontrolled infection
- Infection that is controlled with antibiotics allowed
- No symptomatic cardiac disease
- No active ischemia on EKG
- LVEF ≥ 40% by echocardiogram or MUGA
- Patients with a history of cardiac disease or mediastinal radiation should undergo testing of ventricular function
- No poorly controlled diabetes mellitus
- No psychiatric illness or social situation that would preclude giving informed consent or complying with study requirements
- No HIV positivity
- See Disease Characteristics
- At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for carmustine or mitomycin C) and recovered
- At least 4 weeks since prior radiotherapy and recovered
- At least 4 weeks since prior autologous stem cell transplantation (SCT)
- At least 90 days since prior allogeneic SCT
- No evidence of graft vs host disease
- At least 2 weeks since prior immunosuppressive therapy
- No concurrent hematopoietic growth factors or biologic agents
- No other concurrent investigational agents, chemotherapy, radiotherapy, or immunotherapy
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00301938
Start Date
December 1 2005
Last Update
September 30 2013
Active Locations (1)
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1
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1595