Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

This study has been terminated.
(Drug was not available.)
Sponsor:
Collaborator:
Pfizer
Information provided by:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00276159
First received: January 11, 2006
Last updated: July 7, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Multiple Myeloma
Chronic Lymphocytic Leukemia
Drug: 852A
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    Number of patients who received steroids allowing successful continuation of therapy.

  • Measure of Immune Activation With Correlative Laboratory Studies [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
  • Peak Concentrations of 852A [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.


Enrollment: 6
Study Start Date: January 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276159

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Pfizer
Investigators
Principal Investigator: Sarah Cooley, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Sarah Cooley, M.D., Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00276159     History of Changes
Obsolete Identifiers: NCT00326937
Other Study ID Numbers: 05US02IMP-852A, MT2005-20, 2005LS057, 0509M73467
Study First Received: January 11, 2006
Results First Received: March 2, 2010
Last Updated: July 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
Leukemia
Lymphoma
Myeloma
Hematology
852A
IRM
Oncology

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Neoplasms by Site

ClinicalTrials.gov processed this record on April 17, 2014