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Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma


Phase 1/Phase 2
12 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Steven M. Horwitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

MDX-060-01

NCT ID:

NCT00059995

Start Date:

January 2003

Completion Date:

November 2009

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240