Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Liposome entrapped mitoxantrone (LEM) is a mixture of commercially available mitoxantrone HCL (Novantrone) and a combination of lyophilized lipids. Mitoxantrone, the active agent in the investigational formulation, is a currently marketed chemotherapeutic agent. The rationale for development of liposomal formulations is primarily that of improving the safety profile of the drug, which may permit dose intensification and/or an increase in the cumulative dose that may be administered, resulting in enhanced efficacy.

LEM will be given to patients with advanced solid tumors to determine the dose of drug these patients can tolerate. Patients will receive intravenous LEM every 21 days until the disease progresses or toxicity occurs requiring treatment discontinuation. Anti-tumor effects of LEM will be assessed and patients will be evaluated for safety and tolerability.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: INSYS Therapeutics Inc
• Treatments: Mitoxantrone

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.