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A Phase II Study of Hu1D10 in Recurrent Hodgkin's Disease


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Study of Hu1D10 in Recurrent Hodgkin's Disease


OBJECTIVES:

- Determine the response rate of patients with recurrent Hodgkin's lymphoma treated with
monoclonal antibody Hu1D10.

- Determine the duration of response and progression-free survival of patients treated
with this drug.

- Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive monoclonal antibody Hu1D10 IV over 2 hours. Treatment repeats weekly for a
total of 4 doses in the absence of disease progression or unacceptable toxicity.

Patients are followed at weeks 5 and 8 and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within
approximately 12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed Hodgkin's lymphoma

- Progressive or recurrent disease after standard initial therapy

- At least 1 unidimensionally measurable lesion (at least 15 mm by conventional
techniques)

- Patients in first relapse must be ineligible or unwilling to receive high-dose
therapy and stem cell transplantation

- Evidence of Hu1D10 localization to Reed Sternberg cells by immunohistochemistry

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- More than 6 months

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin normal

- AST and ALT no greater than 2.5 times upper limit of normal

Renal

- Creatinine normal OR

- Creatinine clearance at least 60 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

- HIV negative

- No known human anti-human antibody

- No prior allergic reaction to compounds of similar chemical or biological composition
to monoclonal antibody Hu1D10

- No ongoing or active infection

- No other uncontrolled concurrent illness

- No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- See Chemotherapy

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

- Prior second-line (or greater) high-dose therapy and stem cell transplantation
allowed

Endocrine therapy

- Not specified

Radiotherapy

- At least 4 weeks since prior radiotherapy and recovered

Surgery

- Not specified

Other

- No other concurrent investigational agents

- No other concurrent anticancer agents or therapies

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Sandra J. Horning, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

SUMC-NCI-1951

NCT ID:

NCT00055783

Start Date:

July 2002

Completion Date:

April 2003

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Stanford University Medical CenterStanford, California  94305-5408