Clinical trial NCT00276159: Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
Official title: Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Multiple Myeloma
Chronic Lymphocytic Leukemia
Keywords: Leukemia
Lymphoma
Myeloma
Hematology
852A
IRM
Oncology
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2006-01-13
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 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).

Primary outcomes:
measure: Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
timeFrame: Up to Week 12
Secondary outcomes:
measure: Number of Patients Who Received Steroids
timeFrame: Up to Week 12
measure: Measure of Immune Activation With Correlative Laboratory Studies
timeFrame: Up to Week 12
measure: Peak Concentrations of 852A
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Sarah Cooley, MD
role: PRINCIPAL_INVESTIGATOR
References: