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Phase 1
18 Years
Not Enrolling

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Trial Information


I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of LE-SN38.

II. Determine the plasma pharmacokinetics of SN38 following IV administration of LE-SN38.

III. Observe any anti-tumor effects of LE-SN38.


This is an open-label study in patients with advanced solid tumors who have failed
conventional therapy.

LE-SN38 will be administered IV over 90 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 21-day schedule in the absence of progressive disease or unacceptable toxicity. A
subsequent course of treatment may be administered at least 21 days after receiving a prior
dose of LE-SN38 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.

Disease status will be assessed after every second cycle. In the event of disease
progression, study treatment will be discontinued and all end of treatment study evaluations
will be performed.

PROJECTED ACCRUAL: Up to 40 patients will be enrolled.

Inclusion Criteria

Disease Characteristics:

- Advanced (local and/or metastatic) histologically documented solid tumors

- Disease not considered responsive to available conventional modalities or treatments

- No life prolonging therapy or therapy with a greater potential for patient benefit is

Prior/Concurrent Therapy:

- No treatment with cytotoxic or biologic agents within 3 weeks prior to study entry (6
weeks for radiotherapy, mitomycin and nitrosoureas)

- At least 2 weeks since any prior surgery or hematopoietic growth factor therapy

- Chronic Grade 1 toxicities due to prior treatment or other causes are permitted

Patient Characteristics:

- Must have 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 9 g/dL, albumin at least 3.0 g/dL, serum
creatinine not more than 2.0 mg/dL, total bilirubin not more than the institutional
upper limit of normal, alanine aminotransferase, aspartate aminotransferase, and
alkaline phosphatase not more than 1.5 x the institutional upper limit of normal

- Must sign informed consent

- No active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer

- No infection requiring parenteral antibiotics

- No known HIV infection or viral hepatitis

- No active heart disease including myocardial infarction or congestive heart failure
within the previous 6 months, symptomatic coronary artery disease, arrhythmias
requiring medication

- No known or suspected active CNS metastasis

- No pregnant or nursing female 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 agree to use acceptable contraceptive
methods, e.g., double barrier, during the conduct of the study

- No agent which could interfere with SN38 metabolism, including phenobarbital,
valproic acid, cyclosporine or phenytoin

- No concurrent treatment for cancer or any other investigational agent for any
indication within 30 days prior to receiving the first dose of study drug

- No immediate palliative treatment of any kind including surgery

- No high-dose chemotherapy regimen with stem cell support in the previous 6 months

- No abdominal or pelvic radiation therapy

- Not willing or unable to follow protocol requirements

- No known hypersensitivity to irinotecan, SN38, or liposomes

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mayer Fishman, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida


United States: Food and Drug Administration

Study ID:




Start Date:

October 2002

Completion Date:

November 2010

Related Keywords:

  • Neoplasms
  • Liposome-Encapsulated SN38
  • Irinotecan
  • CPT-11
  • Malignant Tumors
  • Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
The Ohio State University Columbus, Ohio  43210