Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

NCT00276159 | Terminated Phase 2 Results DMC

• 4 other identifiers: 05US02IMP-852AMT2005-202005LS0570509M73467
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Patients Who Received Steroids

  Up to Week 12

• Measure of Immune Activation With Correlative Laboratory Studies

  Up to Week 12

• Peak Concentrations of 852A

  Up to Week 12

Study Arms (1)

852A Treatment

EXPERIMENTAL

Patients receiving at least one dose of 852A.

Drug: 852A

Interventions

852A DRUG

Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.

Also known as: Molecule 852A, S-32865

852A Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• Pfizer: collaborator

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

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

Interventions

N-(4-(4-amino-2-ethyl-1H-imidazo(4,5c)quinolin-1-yl)butyl)methanesulfonamide

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sarah Cooley, MD
• Organization: Masonic Cancer Center, University of Minnesota

cool0023@umn.edu

612-625-8474

Study Officials

• Sarah Cooley, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2006
• First Posted: January 13, 2006
• Study Start: January 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 4, 2019
• Results First Posted: May 5, 2010

Record last verified: 2019-08

Locations

US (1)