search
Back to results

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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
monoclonal antibody HeFi-1
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult Hodgkin lymphoma, anaplastic large cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 25, 2013
Sponsor
Beth Israel Deaconess Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00003741
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma
Official Title
HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent adult Hodgkin lymphoma, anaplastic large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
monoclonal antibody HeFi-1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Koon, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs