Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
Condition: Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Hematologic Neoplasms
Intervention: 852A
Intervention description: Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Healthy volunteers: No
Keywords: Leukemia; Lymphoma; Myeloma; Hematology; 852A; IRM; Oncology

Summary:

      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.
    

Eligibility criteria:

        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).