Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborator: Pfizer

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).