Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

NCT00276159

Last updated date
Study Location
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, Chronic Lymphocytic LeukemiaStudy of Immune Response Modifier in the Treatment of Hematologic Malignancies
NCT00276159
  1. Minneapolis, Minnesota
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
Official Title  ICMJE Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Multiple Myeloma
  • Chronic Lymphocytic Leukemia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 852A Treatment
Patients receiving at least one dose of 852A.
Intervention: Drug: 852A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 14, 2009)
6
Original Enrollment  ICMJE
 (submitted: January 11, 2006)
60
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276159
Other Study ID Numbers  ICMJE 05US02IMP-852A
MT2005-20 ( Other Identifier: Blood and Marrow Transplantation Program )
2005LS057 ( Other Identifier: Clinical Trials Office, University of Minnesota )
0509M73467 ( Other Identifier: IRB, University of Minnesota )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Sarah Cooley, MDMasonic Cancer Center, University of Minnesota
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP