MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Biological: iratumumab


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: iratumumab|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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