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

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