Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

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.

  • acute lymphoblastic leukemia (ALL)
  • acute myeloid leukemia (AML)
  • non-Hodgkin's lymphoma (NHL)
  • Hodgkin's lymphoma (HL)
  • multiple myeloma (MM)
  • chronic lymphocytic leukemia (CLL)
• 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:

  • Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)
  • Investigational drugs/agents within 14 days of first dose of 852A
  • Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose)
  • Drugs known to induce QT interval prolongation and/or induce Torsades De Pointes unless best available drug required to treat life-threatening conditions
  • Radiotherapy within 4 weeks of the first dose of 852A
  • Hematopoietic cell transplantation 4 weeks of first dose of 852A
• 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).