Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

Stopped early · Phase 2

Conditions studied: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT00276159

Run by

Masonic Cancer Center, University of Minnesota

People needed

6

Starts

2006-01-01

Expected to finish

2008-11-01

Last updated by the study team

2019-09-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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