Clinical Drug Experience Knowledgebase

Criteria

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.