MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma

Inclusion Criteria:

• signed informed consent
• confirmed diagnosis of ALCL
• patient with csALCL must be confirmed CD30+
• patients with csALCL must have failed or relapsed following second line (i.e. salvage) chemotherapy or relapsed or failed following autologous stem cell transplant.
• patients with pcALCL must have progressed after treatment with local radiation therapy or surgical excision or failed systemic therapy with a single agent or multi-agent regimen.
• patients with pcALCL must be confirmed CD30+
• ECOG performance of 0 to 2
• at least 12 years of age
• life expectancy 12 weeks or greater
• must meet screening laboratory values
• women must be post-menopausal for at least 1 year; surgically incapable of bearing children; or utilizing a reliable form of contraception. All women must have a negative pregnancy test.
• men must agree to the use of male contraception for the duration of the study
• patients on corticosteroids must be tapered off the medication 2 weeks prior to the first MDX-060 administration and remain off corticosteroids until day 365.

Exclusion Criteria:

• previous treatment with any anti-CD30 antibody
• history of allogenic transplantation
• any tumor lesion 10 cm or greater in diameter
• any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.
• any significant acter or chronic infection.
• prior known serum positivity for HIV, hepatitis B or C as determined at screening.
• treatment with an investigational agent within 30 days or 5 half-lives (whichever is longer) of study screening.
• apparent active or latent tuberculosis infection (TB).
• patients who are pregnant or nursing
• any underlying medical condition which, in the investigator's opinion, will make the administration of MDX-060 hazardous or obscure the interpretation of adverse events.
• concomitant chemotherapy, corticosteroids, investigational agents, other anti-ALCL biologics, or radiation therapy
• patients with mycosis fungoides, or
• patients with recurrent, self-healing papulonodular eruptions only or any other lymphoma other than ALCL.