Sandra Horning
A Phase I Dose Escalation Study of Weekly SGN-35 Alone and in Combination With Gemcitabine in HL
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: SGN-35
Phase:
Phase 1Eligibility
Ages Eligible for Study:
12 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- Current diagnosis of primary cutaneous ALCL
- History of allogeneic stem cell transplant.
- Patients who have had previous treatment with any anti-CD30 antibody.
Additional Study Details
Official Title:
Phase I Dose Escalation Study of Weekly SGN-35 Alone and in Combination with Gemcitabine in Patients with Relapsed/Refractory CD30-Positive Hematologic MalignanciesAnticipated start date:
5/23/2008Lead Sponsor:
Seattle GeneticsInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
SafetyPrimary Outcomes:
- Adverse events; clinical laboratory parameters. [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
Secondary Outcomes:
- PK Profile; Immunogenicity; Cheson Response Criteria. [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
Total Number to be Enrolled:
39Total Number to be Enrolled at Stanford:
4More Information
Secondary ID(s):
- 98710
- LYMHD0004
- NCT00649584
- SG035-0002
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
3/26/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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