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

This study is currently recruiting patients.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
recurrent adult Hodgkin's lymphoma
recurrent/refractory childhood Hodgkin's lymphoma
anaplastic large cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent childhood large cell lymphoma
recurrent cutaneous T-cell lymphoma
 Drug: MDX-060 monoclonal antibody
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: monoclonal antibody therapy
Phase I
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Hodgkin's Disease;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of MDX-060 Monoclonal Antibody in Patients With Refractory or Relapsed CD30-Positive Lymphoma

Further Study Details: 

OBJECTIVES:

  • 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.

Eligibility

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • Over 12

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • 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

Hepatic

  • 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

Renal

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

Other

  • 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

PRIOR CONCURRENT THERAPY: Biologic therapy

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

Chemotherapy

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

Endocrine therapy

Radiotherapy

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

Surgery

  • Not specified

Other


Location and Contact Information


Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Stephen M. Ansell, MD, PhD  507-284-2511 

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Andrew D. Zelenetz, MD, PhD  212-639-5053 

Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
John C. Byrd, MD  614-293-7509    byrd-3@medctr.osu.edu 

Study chairs or principal investigators

Steven M. Horwitz, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000298995; MSKCC-02121; MDX-060-01; NCT00059995
Record last reviewed:  April 2003
Last Updated:  January 6, 2005
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00059995
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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