Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

University of Minnesota (UMN)

Status and phase

Terminated

Phase 2

Conditions

Hodgkin's Lymphoma

Multiple Myeloma

Non-Hodgkin's Lymphoma

Chronic Lymphocytic Leukemia

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Treatments

Drug: 852A

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00276159

0509M73467 (Other Identifier)

MT2005-20 (Other Identifier)

05US02IMP-852A

2005LS057 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

6 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).