Advanced Solid Tumors, Solid Tumors
Conditions
Brief summary
This study is being done to: * Test the safety of EP-100 and see what effect (good and bad) it has on the patient and their cancer; * Find the highest dose of EP-100 that can be given without causing bad side effects; * Examine how much EP-100 is in the blood at certain times after it is given and how quickly the body gets rid of it; * Observe whether there is any effect of EP-100 on the size and activity of cancer in the patient's body.
Interventions
DRUGEP-100
as a single agent administered intravenously twice weekly x 3 with 1 week off (total 28 days)
Sponsors
Esperance Pharmaceuticals Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with histologically confirmed solid carcinomas * Subjects whose tumors over express LHRH receptors in tumor biopsies * Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy * One or more metastatic tumors measurable on CT scan or evaluable disease * Karnofsky performance ≥ 70% * Life expectancy of at least 3 months * Age greater than or equal to 18 years * Signed, written informed consent. Consent must be provided prior to performing any study-related procedures. * A negative pregnancy test (if female) * Acceptable liver function * Acceptable renal function * Serum creatinine within normal limits, OR calculated creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal. * Acceptable hematologic status: * No clinically significant abnormalities * Acceptable coagulation status: * For men and women of child-producing potential, the use of effective contraceptive methods during the study
Exclusion criteria
* New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * Pregnant or nursing women. NOTE: Women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Treatment with radiation therapy or investigational therapy within 4 weeks prior to Day 1. Had received chemotherapy prior to study entry equivalent within 3 to 5 half-lives of that chemotherapy agent or 4 weeks prior to study entry (whichever is shorter) with resolution of any side effects from that previous therapy (6 weeks for nitrosoureas or Mitomycin C). * Subjects with active CNS metastases are excluded. * Subjects with a history of CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be off steroids. * Had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1 * Had minor surgery within 2 weeks prior to Day 1 * Patients who may benefit from hormonal treatment such as breast cancer patients whose tumors are hormone receptor positive (ER/PR) and without rapidly progressive visceral disease or patients with prostate cancer who have not had hormonal manipulation therapy. * Patients who have potentially life-threatening disease (hypercalcemia, spinal cord compression) whose disease may acutely progress if EP-100 administration causes a flare reaction. * Unwillingness or inability to comply with procedures required in this protocol * Known infection with HIV, hepatitis B, or hepatitis C * Subjects who are susceptible to histamine release (e.g. patients with mastocytosis, mastocytoma, mast cell leukemia, asthma, hay fever, and other allergic disorders and disorders that increase mast cell numbers). * Patients under chronic treatment with corticosteroids. * Baseline QTc exceeding 450 msec (using the Bazetts formula) and/or patients receiving class 1A or class III antiarrythmic agents. * Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor * Subjects who are currently receiving any other investigational agent * Subjects should not be using any LHRH agonists (such as leuprolide \[Lupron, Eligard\], buserelin \[Suprefact, Suprecor\], nafarelin \[Synarel\], histrelin \[Supprelin\], goserelin \[Zoladex\], deslorelin \[Suprelorin, Ovuplant\], Triptorelin and others) or antagonists (such as Abarelix \[Plenaxis\], Cetrorelix \[Cetrotide\], Ganirelix \[Antagon\] and others) prior to study treatments. If LHRH agonists are being used, a 4-week washout period is recommended.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of EP-100 | weekly |
| To establish the dose of EP-100 recommended for future phase II protocols | weekly |
Countries
United States
Outcome results
None listed