Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Boston, Massachusetts 02215


RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.

Study summary:

OBJECTIVES: - Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30+ anaplastic large cell lymphoma or Hodgkin's lymphoma. - Determine the pharmacokinetics of this drug in this patient population. - Evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks. Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response. Responding patients may continue treatment at monthly intervals for one year. Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity. Patients are followed monthly. PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.


DISEASE CHARACTERISTICS: - Histologically confirmed CD30+ anaplastic large cell lymphoma (ALCL) or Hodgkin's lymphoma - At least 50% of malignant cells must react with HeFi-1 - HIV positive or HIV negative - Measurable disease - No symptomatic CNS disease - Must have failed or be ineligible for standard chemotherapy regimen PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Not specified Life expectancy: - More than 2 months Hematopoietic: - Not specified Hepatic: - No significant hepatic disease - Bilirubin no greater than 2 mg/dL Renal: - No significant renal disease - Creatinine no greater than 3 mg/dL Cardiovascular: - No significant cardiovascular disease Pulmonary: - No significant pulmonary disease Other: - No significant endocrine, rheumatologic, or allergic disease - No active clinical disease caused by cytomegalovirus (CMV), herpes simplex virus (HSV) I, HSV II, hepatitis B, or tuberculosis - Not pregnant - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior murine antibody therapy Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy to measurable disease Surgery: - Not specified Other - At least 4 weeks since prior cytotoxic therapy to measurable disease



Primary Contact:

Study Chair
Henry Koon, MD
Beth Israel Deaconess Medical Center

Backup Contact:


Location Contact:

Boston, Massachusetts 02215
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.