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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Multiple Myeloma
Neoplasms, Plasma Cell
Hodgkin Disease
Lymphoma
Leukemia
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

ClinicalTrials.gov processed this record on September 22, 2014