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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 Center New York, New York  10021
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240