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

Primary Purpose

Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SGN-35

gemcitabine

About this trial

This is an interventional treatment trial for Disease, Hodgkin focused on measuring Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, monomethyl auristatin E, Combined Modality Therapy, Drug Therapy, Immunotherapy, Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Hematologic Diseases, Lymphoma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

University of Alabama at Birmingham
Stanford University Medical Center
University of Miami
Washington University School of Medicine
University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

SGN-35 alone or in combination with gemcitabine

Outcomes

Primary Outcome Measures

Incidence of adverse events and laboratory abnormalities

Secondary Outcome Measures

PK profile

Immunogenicity (anti-SGN-35 antibodies)

Anti-tumor activity

Full Information

NCT ID

NCT00649584

First Posted

March 27, 2008

Last Updated

December 17, 2014

Sponsor

Seagen Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00649584

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision not to enroll cohorts of combined SGN-35 and gemcitabine therapy.

Study Start Date

March 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seagen Inc.

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

Keywords

Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, monomethyl auristatin E, Combined Modality Therapy, Drug Therapy, Immunotherapy, Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Hematologic Diseases, Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

SGN-35 alone or in combination with gemcitabine

Intervention Type

Drug

Intervention Name(s)

SGN-35

Other Intervention Name(s)

brentuximab vedotin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of adverse events and laboratory abnormalities

Time Frame

1 month after last dose

Secondary Outcome Measure Information:

Title

PK profile

Time Frame

2 months after last dose

Title

Immunogenicity (anti-SGN-35 antibodies)

Time Frame

1 month after last dose

Title

Anti-tumor activity

Time Frame

1 month after last dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dana Kennedy, PharmD

Organizational Affiliation

Seagen Inc.

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294-3300

Country

United States

Facility Name

Stanford University Medical Center

City

Palo Alto

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Washington University School of Medicine

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4003

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22080439

Citation

Fanale MA, Forero-Torres A, Rosenblatt JD, Advani RH, Franklin AR, Kennedy DA, Han TH, Sievers EL, Bartlett NL. A phase I weekly dosing study of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies. Clin Cancer Res. 2012 Jan 1;18(1):248-55. doi: 10.1158/1078-0432.CCR-11-1425. Epub 2011 Nov 11.

Results Reference

result

Learn more about this trial

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

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