HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study
monoclonal antibody HeFi-1
Hemic and Lymphatic Diseases+9
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: February 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Beth Israel Deaconess Medical Center
Boston, United StatesOpen Beth Israel Deaconess Medical Center in Google Maps