Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	Other	BIDMC-97127 NEDH-97127, NCI-870, NCI-V99-1515, NCT00003741, 870

Objectives

1. 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.
2. Determine the pharmacokinetics of this drug in this patient population.
3. Evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients.

Entry 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

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

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

Expected Enrollment

A total of 9 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Beth Israel Deaconess Medical Center

Henry Koon, MD, Protocol chair		Ph: 617-667-9900

Registry Information
Official Title		HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study
Trial Start Date		1999-02-01
Registered in ClinicalTrials.gov		NCT00003741
Date Submitted to PDQ		1999-01-12
Information Last Verified		2005-03-24