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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Lymphoma

Treatments

Biological: iratumumab

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00059995
MDX-060-01
CDR0000298995 (Registry Identifier)
MSKCC-02121

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

  • 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)

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

  • No concurrent systemic steroidal therapy (excluding physiologic doses)

Radiotherapy

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

Surgery

  • Not specified

Other

  • No other concurrent investigational agents

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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