View Clinical Trial (Medical Research Study)
A Phase I Study of IHL-305 (Irinotecan Liposome Injection) in Patients With Advanced Solid Tumors
| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37232 |
| Conditions: |
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Cancer |
| Purpose: |
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The purpose of this study is to determine whether IHL-305 (irinotecan liposome injection) is
safe and effective in the treatment of advanced solid tumors.
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| Study Summary: |
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This is a Phase I dose-escalation study of intravenous administration of IHL-305 in patients
with advanced solid tumors. Patients will receive IHL-305 as an intravenous infusion over 60
minutes on Day 1 followed by a 27-day observation period for a total of 28 days (4 weeks)
per cycle. Two patient populations will be evaluated separately; patients with UGT1A1*28
genotype homozygous wild-type (wt/wt) and heterozygous (wt/*28) variants as one group, and
patients with UGT1A1*28 homozygous variant (*28/*28) as another group.
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| Criteria: |
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Inclusion Criteria:
1. Histologically confirmed malignant solid tumor and not a candidate for known regimens
or protocol treatments of higher efficacy or priority
2. Failed conventional therapy for their cancer or have a malignancy for which a
conventional therapy does not exist
3. Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair
loss)
4. ECOG performance status of 0, 1, or 2
5. 18 years of age or older
6. Normal organ and bone marrow function as defined by:
- absolute neutrophil count greater than or equal to 1,500 cells/microliter
- platelets greater than or equal to 100,000 cells/microliter
- total bilirubin within normal institutional limits
- AST (SGOT)/ALT (SGPT) less than or equal to 2.5 x institutional upper limit of
normal (ULN) or less than or equal to 5.0 x ULN in patients with liver
metastases
- plasma creatinine less than or equal to 1.5 x institutional ULN OR
- creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients
with creatinine levels above institutional normal
7. Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
1. Previously treated with irinotecan, or had chemotherapy or radiotherapy within 4
weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or not
recovered from adverse effects due to agents administered more than 4 weeks earlier
2. Receiving any other investigational agent
3. Known brain metastases
4. History of allergic reactions attributed to compounds of similar chemical composition
to IHL-305
5. Concurrent serious infections (i.e., requiring an intravenous antibiotic)
6. Pregnant women or women of childbearing potential and not using methods to avoid
pregnancy; a negative pregnancy test (urine or serum) must be documented at baseline
for women of childbearing potential; no breast-feeding while on study.
7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, unstable angina pectoris, or psychiatric illness/social situations that
would limit compliance with study requirements
8. Significant cardiac disease including heart failure that meets New York Heart
Association (NYHA) class III and IV definitions; history of myocardial infarction
within one year of study entry; uncontrolled dysrhythmias; or poorly controlled
angina.
9. History of serious ventricular arrhythmia (ventricular tachycardia [VT] or
ventricular fibrillation [VF], greater than or equal to 3 beats in a row); QTc
greater than or equal to 450 msec for men and 470 msec for women; or left ventricular
ejection fraction (LVEF) less than or equal to 40% by multi-gated acquisition scan
(MUGA).
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| NCT ID: |
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NCT00364143 |
| Primary Contact: |
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Principal Investigator
Mace L Rothenberg, M.D.
Vanderbilt University
Christina A Weaver, BS
Phone: 609-799-7580 ext. 406
Email: cweaver@theradex.com
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| Backup Contact: |
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Email: bdavis@theradex.com
Brad Davis
Phone: 609-799-7580 ext. 394
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| Location Contact: |
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Nashville, Tennessee 37232
United States
Wendy L. VerMeulen, RN, BSN
Phone: 615-343-0798
Email: wendy.vermeulen@vanderbilt.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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