Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment
Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability
Subjects are eligible for the study if they meet all of the following
Inclusion Criteria:
Diagnosis of one of the following hematologic malignancies not responding to at least 2 standard treatment regimens. Any criteria for persistent or recurrent disease acceptable, i.e. ≥5% blasts for acute leukemia.
Performance status - Karnofsky > 50% for patients > 10 years of age or Lansky >50% for patients < 10 year of age
Normal organ function within 14 days of study entry
If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation. A female is considered to be of childbearing potential unless she has had her uterus removed, had a double oophorectomy, or has been amenorrheic for at least 6 months after chemotherapy
Exclusion Criteria:
Had/have the following prior/concurrent therapy:
Active infection or fever > 38.5°C within 3 days of first dose of 852A
Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication
History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
Uncontrolled intercurrent or chronic illness
Active autoimmune disease requiring immunosuppressive therapy within 30 days
Active hepatitis B or C with evidence of ongoing viral replication
Hyperthyroidism
Uncontrolled seizure disorder
Active coagulation disorder not controlled with medication
Pregnant or lactating
Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas adequately treated
Proven active central nervous system (CNS) disease
Human Immunodeficiency Virus (HIV) positive
Congenital long QT syndrome or abnormal baseline QTc interval (> 450 msec in males and > 470 msec in females) after Bazett's correction (QTc msec = QT msec / square root of the RR interval in seconds) on screening electrocardiogram (ECG).