Lymphoid Malignancies
Conditions
Brief summary
The purpose of this study is to determine if HGS1029 is safe and well tolerated in patients with relapsed or refractory lymphoid malignancies.
Interventions
DRUGHGS1029
HGS1029 will be given as a 15-minute IV infusion (in the vein) once weekly for 3 consecutive weeks, followed by 1 week off.
Sponsors
Human Genome Sciences Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed relapsed/refractory lymphoid malignancies * Previously treated with at least 2 therapeutic regimens * ECOG performance \< 2. * Life expectancy of at least 3 months * Adequate renal function * Adequate hematologic status * Adequate liver function * Transfusion independent
Exclusion criteria
* Received other therapy (biological or drug) to treat cancer within 4 weeks prior to starting treatment with HGS1029 or who exhibit persistent clinical evidence of cancer treatment toxicity * The use of systemic corticosteroids within 1 week of starting treatment with HGS1029 * Evidence of active bacterial, viral or fungal infection within 2 weeks before starting treatment with HGS1029 * Known HIV infection * Positive for hepatitis B surface antigen or positive hepatitis C antibody * Grade 2 or greater neuropathy * Pregnant female or nursing mother * Males or females who do not agree to use effective contraception during the study and through at least 30 days after the last dose of HGS1029
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type, frequency and severity of adverse events | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Measure pharmacokinetic profile | 1st two months of the study |
| Evaluation of pharmacodynamics | 1st two months of the study |
| Evaluation of possible anti-tumor activity | Every 2 months while on study |
Countries
United Kingdom, United States
Outcome results
None listed