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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003741
• Other study ID #: BIDMC-97127
• Secondary ID: CDR0000066859NED
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: June 25, 2013
• Start date: February 1999
• Est. completion date: December 2007

Study information

• Verified date: March 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic

Intervention

Biological:
• monoclonal antibody HeFi-1

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States,