Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

Multiple Myeloma Clinical Trial

Official title:

Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00276159
• Other study ID #: 05US02IMP-852A
• Secondary ID: MT2005-202005LS0
• Status: Terminated
• Phase: Phase 2
• Start date: January 2006
• Est. completion date: November 2008

Study information

• Verified date: August 2019
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Other known NCT identifiers

• NCT00326937

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Chronic Lymphocytic Leukemia
• Hodgkin's Lymphoma
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Multiple Myeloma
• Non-Hodgkin's Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• 852A
Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors	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.	Up to Week 12
Secondary	Number of Patients Who Received Steroids	Number of patients who received steroids allowing successful continuation of therapy.	Up to Week 12
Secondary	Measure of Immune Activation With Correlative Laboratory Studies		Up to Week 12
Secondary	Peak Concentrations of 852A	Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.	Up to Week 12