An Open-label, Fixed-dose, Multicenter, Phase II Study of MDX-060 in Patients with Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma - Not Available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

1. Patient or guardian must have read, understood, and provided written informed consent after the nature of the study has been fully explained. Patients 12 through 17 years old must also provide written assent
2. Confirmed diagnosis of ALCL (excluding HIV-associated ALCL)
3. Patients with csALCL must have a histologically confirmed diagnosis of CD30+ ALCL and confirmation of anaplastic lymphoma kinase status (positive or negative)
4. Patients with csALCL must have failed or relapsed following second line chemotherapy or relapsed or failed following autolougus stem cell transplant. Patients who are not candidates for stem cell transplant, exhibitit chemo-resistant disease, or refuse further chemotherapy may also be included.
5. 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
6. Patients with pcALCL must have a histologically confirmed diagnosis of CD30+ ALCL within the past 12 months
7. ECOG Performance Status of 0 to 2
8. Patients must have bidirectionally measurable disease
9. At least 4 weeks since the last chemotherapy or radiation therapy prior to dosing of MDX-060 and have recovered from any toxicity associated with such treatment or returned to baseline
10. At lease 12 years of age
11. Life expectancy of 12 weeks or more
12. Screening laboratory valuse must meet criteria
13. Women must either 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 during screening
14. Men must agree to the use of male contraception for the duration of the study
15. 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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Previous treatment with any anti-CD30 antibody
2. History of allogenic transplantation
3. Any tumor lesion 10cm or greater in diameter
4. 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
5. Any significant active or chronic infection
6. Prior known serum positivity for HIV antibodies, hepatitis B antigenemia, or hepatitis C veremia, as determined at screening
7. Treatment with investigational agent within 30 days or 5 half-lives (whichever is longer) of study screening
8. Apparent active or latent tuberculosis infection
9. Patients who are pregnant or nursing
10. Any underlying medical condition which, in the Principal Investigator's opinion, will make the administration of MDX-060 hazardous or obscure the interpretation of adverse events
11. Concomitant chemotherapy, corticosteroids, investigational agents, other anti-ALCL biologics, or radiation therapy
12. Patients with mycosis fungoides
13. Patients with recurrent, self-healing papulonodular eruptions only or any other lymphoma other than ALCL

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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