Status:
TERMINATED
Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
Pfizer
Conditions:
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Eligibility:
All Genders
Phase:
PHASE2
Brief 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.
Detailed Description
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
Eligibility Criteria
Inclusion
- Subjects are eligible for the study if they meet all of the following
- 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
- 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).
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00276159
Start Date
January 1 2006
End Date
November 1 2008
Last Update
September 4 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455