Status:
TERMINATED
A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies
Lead Sponsor:
Seagen Inc.
Conditions:
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.
Eligibility Criteria
Inclusion
- Histologically confirmed CD30-positive hematologic malignancy.
- Patients with HL must have failed systemic chemotherapy.
- Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
- Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.
Exclusion
- Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
- History of allogeneic stem cell transplant.
- Patients who have had previous treatment with any anti-CD30 antibody.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00649584
Start Date
March 1 2008
End Date
February 1 2010
Last Update
December 18 2014
Active Locations (5)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
2
Stanford University Medical Center
Palo Alto, California, United States, 94305
3
University of Miami
Miami, Florida, United States, 33136
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110