Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Myeloid Leukemia; Multiple Myeloma; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Acute Lymphoblastic Leukemia; Chronic Lymphocytic Leukemia
• Intervention / Treatment: Drug: 852A

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

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 852A Treatment; Patients receiving at least one dose of 852A.	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.; Other Names: Molecule 852A; S-32865

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: Pfizer
• Investigators: Principal Investigator: Sarah Cooley, MD, Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: January 11, 2006
• First Submitted That Met QC Criteria: January 11, 2006
• First Posted (Estimate): January 13, 2006

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Lymphoma; Leukemia; Oncology; Hematology; Myeloma; IRM; 852A
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Neoplasms by Site; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Leukemia, Lymphoid; Leukemia, B-Cell; Lymphoma; Hematologic Neoplasms; Multiple Myeloma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell
• Other Study ID Numbers: 05US02IMP-852A; MT2005-20 (Other Identifier: Blood and Marrow Transplantation Program); 2005LS057 (Other Identifier: Clinical Trials Office, University of Minnesota); 0509M73467 (Other Identifier: IRB, University of Minnesota)