18 Years
N/A
Both
Tumors
Trial Information
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT)
of LEM.
II. Measure the blood pharmacokinetics of LEM following IV administration.
III. Observe any anti-tumor effects of LEM.
PROTOCOL OUTLINE: This is an open-label study for patients with advanced and/or metastatic,
histologically-documented solid tumors considered to be unresponsive to available
conventional treatment.
LEM will be administered IV over 45 minutes. At least three patients will be studied at
each dose level and at least three patients will complete one 21-day course before any
patient is enrolled at the next dose level. Study drug administration will continue on an
every 3-week schedule in the absence of progressive disease or unacceptable toxicity. A
subsequent course of treatment may be administered at least 21 days after a prior LEM dose
has been administered when study criteria are met.
Cohorts of 3 patients per dose level will be studied. This will be expanded to 6 if a DLT
occurs, followed by a total of 6 patients at a possible MTD.
PROJECTED ACCRUAL: It is expected that 21 to 30 patients will be entered into the study to
determine the MTD: 3 per dose level, expanded to 6 if DLT occurs, followed by a total of 6
patients at a possible MTD. The dose level identified as the MTD may then be expanded up to
12 patients to permit additional safety assessment.
Inclusion Criteria
-Disease Characteristics-
Advanced (local and/or metastatic) histologically documented solid tumors
Disease is not considered responsive to available conventional modalities or treatments
-Prior/Concurrent Therapy-
Must be fully recovered from acute toxicities of any prior treatment with cytotoxic drugs,
radiotherapy or other anti-cancer modalities (returned to baseline before most recent
treatment)
No radiotherapy, treatment with cytotoxic or biologic agents within 3 weeks prior to study
entry (6 weeks for mitomycin or nitrosoureas)
At least 2 weeks after any prior surgery or hormonal therapy
Chronic toxicities of grade 1 from prior treatment are permitted
-Patient Characteristics-
ECOG Performance status of 0-2
Must be at least 18 years of age
Must have the following clinical laboratory values: ANC at least 1,500/mm3; Platelets at
least 100,000/mm3; Hemoglobin at least 10 g/dL; albumin at least 3.0 mg/dL; Serum
creatinine at least 2.0 mg/dL; Total bilirubin not more than upper limit of normal; ALT,
AST, and alkaline phosphatase not more than 1.5 x upper limit of normal; LVEF by MUGA scan
greater than or equal to the lower limit of normal
Must sign informed consent
No pregnant and/or nursing patients. Women of child-bearing potential must have negative
serum or urine pregnancy test within 1 week prior to study entry. Sexually-active patients
(both men and women) must use acceptable contraceptive methods.
No active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease)
No active infection of any kind
No known HIV infection or viral hepatitis
No active heart disease including myocardial infarction within the previous 6 months,
symptomatic coronary artery disease, arrhythmias requiring medication, or congestive heart
failure
No known CNS metastases
No patients receiving any other standard or investigational treatment for their cancer, or
any other investigational agent for any indication
No patients requiring immediate palliative treatment of any kind including surgery
No patients who have received a high-dose chemotherapy regimen with stem cell support in
the previous 6 months
No patients who have received a cumulative anthracycline dose greater than 250 mg/m2
(doxorubicin equivalent)
No patients unwilling or unable to follow protocol requirements
No patients with known hypersensitivity to mitoxantrone or liposomes.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Przemyslaw Twardowski, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope National Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
LEM-001
NCT ID:
NCT00024492
Start Date:
August 2001
Completion Date:
June 2004
Related Keywords:
- Tumors
- Liposome Encapsulated Mitoxantrone (LEM)
- solid tumors
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| City of Hope National Medical Center | Los Angeles, California 91010 |
| The Ohio State University | Columbus, Ohio 43210 |
