A Phase II Study of Hu1D10 in Recurrent Hodgkin's Disease
18 Years
N/A
Both
Lymphoma
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 Center | Stanford, California 94305-5408 |
