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Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00014560
Recruitment Status : Terminated (Medarex (supplier of BsAb) stopped study due to toxicities experienced at other sites on unrelated trials halting manufacturing of BsAb)
First Posted : July 30, 2003
Results First Posted : August 5, 2013
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Description
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Brief Summary:

RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: bispecific antibody 4G7xH22 Biological: sargramostim Phase 1

Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxicity of bispecific antibody 4G7xH22 in patients with relapsed or refractory non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
  • Assess the clinical toxicity of this antibody in these patients.

OUTLINE: This is a dose escalation study of bispecific antibody (BsAb) 4G7xH22.

Patients receive sargramostim (GM-CSF) subcutaneously on day 1 and BsAb 4G7xH22 IV over 2 hours on day 2. Treatment repeats weekly for a total of 3 courses in the absence of unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BsAb 4G7xH22 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.

Patients are followed weekly for 4 weeks, monthly for 3 months, and then periodically for 1 year.

PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial Of Intravenous Bispecific Antibody (4G7XH22) In Patients With Refractory Or Relapsed Non-Hodgkin's Lymphoma Or Chronic Lymphocytic Leukemia (CLL)
Actual Study Start Date : September 28, 2000
Actual Primary Completion Date : February 14, 2003
Actual Study Completion Date : February 14, 2003

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm
Antibody
 Biological: bispecific antibody 4G7xH22
Biological: sargramostim


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Toxicity [ Time Frame: day 1-29 ]
    This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).

  2. Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of BsAb 4G7 x 22 [ Time Frame: Day 1-29 ]
    This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).


Secondary Outcome Measures :
  1. Serum Markers of Macrophage Activation [ Time Frame: Day 1 Hours 0,2,4,6,24, day 15 Hours 0,2,4,6,24 ]
    This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of CD19+ non-Hodgkin's lymphoma or chronic lymphocytic leukemia

    • Primary refractory or multiply relapsed (after at least 2 prior chemotherapy regimens) disease
    • Ineligible for bone marrow or peripheral blood stem cell transplantation

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC greater than 3,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • Alkaline phosphatase less than 2 times normal
  • SGPT less than 2 times normal

Renal:

  • Creatinine clearance greater than 50 mL/min

Other:

  • No human-anti-murine-antibody response to prior murine monoclonal antibodies
  • No immunological or inflammatory disease (e.g., lupus erythematosus)
  • No active serious infection
  • No other serious medical condition that would limit survival to less than 2 years
  • No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
  • No psychiatric or addictive disorder that would preclude study
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior immunotherapy allowed

Chemotherapy:

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy:

  • Concurrent steroids for adrenal failure or adverse reactions to study drug allowed
  • Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014560


Locations
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United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Investigators
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Study Chair: Pamela Ely, MD Norris Cotton Cancer Center
More Information
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Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00014560    
Other Study ID Numbers: CDR0000068556
P30CA023108 ( U.S. NIH Grant/Contract )
DMS-9806
NCI-G01-1936
First Posted: July 30, 2003    Key Record Dates
Results First Posted: August 5, 2013
Last Update Posted: May 3, 2018
Last Verified: April 2018
Keywords provided by Dartmouth-Hitchcock Medical Center:
refractory chronic lymphocytic leukemia
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
 recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
recurrent small lymphocytic lymphoma
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies
Sargramostim
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs