A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies

Sponsor

Seagen Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00649584

Collaborator

(none)

Enrollment

Locations

Arm

23.1

Duration (Months)

8.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin	Drug: SGN-35 Drug: gemcitabine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 SGN-35 alone or in combination with gemcitabine	Drug: SGN-35 IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles Other Names: brentuximab vedotin Drug: gemcitabine IV; 1000 mg/m2 weekly 3 out of 4 weeks Other Names: Gemzar

Arm

Intervention/Treatment

Experimental: 1

SGN-35 alone or in combination with gemcitabine

Drug: SGN-35

IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles

Other Names:

brentuximab vedotin

Drug: gemcitabine

IV; 1000 mg/m2 weekly 3 out of 4 weeks

Other Names:

Gemzar

Outcome Measures

Primary Outcome Measures

Incidence of adverse events and laboratory abnormalities [1 month after last dose]

Secondary Outcome Measures

PK profile [2 months after last dose]
Immunogenicity (anti-SGN-35 antibodies) [1 month after last dose]
Anti-tumor activity [1 month after last dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030-4003