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MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma

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. Identifier: NCT00059995
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : May 30, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: iratumumab Phase 1 Phase 2

Detailed Description:


  • Determine the safety and tolerability of MDX-060 monoclonal antibody in patients with refractory or relapsed CD30-positive lymphoma.
  • Determine the maximum tolerated dose and dose-limiting toxicity of this drug in these patients.
  • Determine the pharmacokinetic profile of this drug in these patients.
  • Determine, preliminarily, the efficacy (antilymphoma activity) of this drug in these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study.

Patients receive MDX-060 monoclonal antibody IV over 90 minutes once weekly for 4 weeks.

Cohorts of 3-6 patients receive escalating doses of MDX-060 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 16 patients are accrued and receive MDX-060 monoclonal antibody at the MTD.

Patients are followed monthly for 3 months and then every 3 months for 18 months or until disease progression.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma
Study Start Date : January 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : November 2009

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed B-cell or T-cell lymphoma

    • Hodgkin's lymphoma and anaplastic large cell lymphoma eligible
    • No HIV-associated lymphoma
  • CD30-positive disease by biopsy, flow cytometry, or immunohistochemistry

    • At least 50% of malignant cells (specifically Reed-Sternberg cells for Hodgkin's lymphoma) must express CD30
  • Must meet one of the following criteria for relapsed/refractory disease:

    • Relapsed after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate)

      • Relapsed disease must be within the prior irradiated field
    • Disease that is refractory to prior chemotherapy or radiotherapy with no other curative treatment option

      • Disease progression must be within the prior irradiated field
  • Progressive and evaluable disease (measurable disease required for patients accrued on study after the maximum tolerated dose is determined)



  • Over 12

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


  • WBC at least 1,500/mm^3*
  • Neutrophil count at least 1,000/mm^3*
  • Platelet count at least 75,000/mm^3*
  • Hemoglobin at least 8.0 g/dL* NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed


  • AST no greater than 2 times upper limit of normal (ULN)*
  • Bilirubin no greater than 2.0 mg/dL (unless due to Gilbert's syndrome)*
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed


  • Creatinine no greater than 2 times ULN* NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 9 months after study participation
  • HIV negative
  • No other active malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No active significant infection
  • No apparent opportunistic infection, as indicated by any of the following:

    • Purified protein derivative recently determined to be positive
    • Infectious infiltrate by chest x-ray
    • Recent changes in fever/chill patterns
    • New, unexplained neurological symptoms
  • No underlying medical condition that would preclude receiving study therapy


Biologic therapy

  • See Disease Characteristics
  • No prior anti-CD30 antibody therapy
  • No other concurrent biologic therapy


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent systemic steroidal therapy (excluding physiologic doses)


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • Not specified


  • No other concurrent investigational agents

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 identifier (NCT number): NCT00059995

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United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Steven M. Horwitz, MD Memorial Sloan Kettering Cancer Center
Publications of Results:
Layout table for additonal information Identifier: NCT00059995    
Other Study ID Numbers: MDX-060-01
CDR0000298995 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: November 2009
Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
anaplastic large cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent childhood large cell lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases