Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma

HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003741

Enrollment

Unknown

Registered

2003-01-27

Start date

1999-02-28

Completion date

2007-12-31

Last updated

2013-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma, anaplastic large cell lymphoma

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALmonoclonal antibody HeFi-1

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026