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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Henry Koon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Federal Government

Study ID:

BIDMC-97127

NCT ID:

NCT00003741

Start Date:

February 1999

Completion Date:

December 2007

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • anaplastic large cell lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Large-Cell, Anaplastic

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215