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Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
This study has been completed.
First Received: January 11, 2006   Last Updated: June 23, 2009   History of Changes
Sponsors and Collaborators: Masonic Cancer Center, University of Minnesota
Pfizer
Information provided by: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00276159
  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 II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:
  • to assess anti-tumor activity of 852A using RECIST criteria to evaluate tumor response after 24 doses or within 2 weeks of last dose

Secondary Outcome Measures:
  • to assess the safety and tolerability of 852A when administered as a subcutaneous injection twice a week for 12 weeks using CTCAE v.3 to grading toxicities throughout the study
  • to assess whether steroids increase prolonged and tolerable drug administration
  • to measure immune activation with correlative laboratory studies
  • to measure peak concentrations of 852A to correlate with tolerability and side effect profile

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)
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 (appendix I)
  • 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

Subjects will be excluded from the study if they meet any of the following 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 (see medication list in appendix II)
    • 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 CNS disease
  • 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 ECG.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276159

Locations
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Pfizer
  More Information

No publications provided

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: 05US02IMP-852A [Miller], MT2005-20
Study First Received: January 11, 2006
Last Updated: June 23, 2009
ClinicalTrials.gov Identifier: NCT00276159     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Leukemia, Lymphoid
Hematologic Neoplasms
Blood Protein Disorders
Paraproteinemias
Leukemia, Myeloid, Acute
Hemostatic Disorders
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia
Acute Myelocytic Leukemia
Hemorrhagic Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, Chronic
Hodgkin Disease
Lymphoma
Acute Lymphoblastic Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Hodgkin's Disease
Leukemia, Myeloid
Multiple Myeloma
Lymphatic Diseases
Chronic Lymphocytic Leukemia
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

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

ClinicalTrials.gov processed this record on September 11, 2009