Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

Phase 2

Terminated

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

Interventions: Drug: 852A

Registration Number: NCT00276159

Lead Sponsor: Masonic Cancer Center, University of Minnesota

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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 6

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
852A Treatment	852A	Patients receiving at least one dose of 852A.

Primary Outcome Measures

Name	Time	Method
Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors	Up to Week 12	Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (\> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = \<5% blasts with hematopoietic recovery (absolute neutrophil count \>500) at 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Received Steroids	Up to Week 12	Number of patients who received steroids allowing successful continuation of therapy.
Measure of Immune Activation With Correlative Laboratory Studies	Up to Week 12
Peak Concentrations of 852A	Up to Week 12	Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.