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Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

Primary Purpose

Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Non-Hodgkin's Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
852A
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Leukemia, Lymphoma, Myeloma, Hematology, 852A, IRM, Oncology

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Masonic Cancer Center, University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

852A Treatment

Arm Description

Patients receiving at least one dose of 852A.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2006
Last Updated
August 21, 2019
Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00276159
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Drug was not available.
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
852A Treatment
Arm Type
Experimental
Arm Description
Patients receiving at least one dose of 852A.
Intervention Type
Drug
Intervention Name(s)
852A
Other Intervention Name(s)
Molecule 852A, S-32865
Intervention Description
Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.
Primary Outcome Measure Information:
Title
Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
Description
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.
Time Frame
Up to Week 12
Secondary Outcome Measure Information:
Title
Number of Patients Who Received Steroids
Description
Number of patients who received steroids allowing successful continuation of therapy.
Time Frame
Up to Week 12
Title
Measure of Immune Activation With Correlative Laboratory Studies
Time Frame
Up to Week 12
Title
Peak Concentrations of 852A
Description
Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.
Time Frame
Up to Week 12

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Cooley, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

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