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Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma (MDX1401-01)

Primary Purpose

Hodgkin's Lymphomas

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MDX-1401
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin's Lymphomas focused on measuring Hodgkin's, Cancer, bi-measurable disease, Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry
  • Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant
  • Bi-measurable disease
  • ECOG Performance Status of 0 - 2
  • Meet all screening laboratory values

Exclusion Criteria:

  • Previous treatment with any other anti-CD30 antibody
  • History of allogeneic transplant
  • Any tumor lesion greater than or equal to 10 cm in diameter
  • Any active or chronic significant infection
  • Underlying medical condition which will make the administration of MDX- 1401 hazardous
  • Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy

Sites / Locations

  • Winship Cancer Institute, Emory University
  • Northwestern University Feinberg School of Medicine
  • Memorial Sloan Kettering Cancer Center
  • ClinWorks Cancer Research Center
  • Scott and White Memorial Hospital and Clinic
  • West Virginia University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MDX-1401

Arm Description

MDX-1401 iv at various doses

Outcomes

Primary Outcome Measures

Safety and Tolerability Profile

Secondary Outcome Measures

Objective Response Rate (ORR)
Tumor response assessment

Full Information

First Posted
February 26, 2008
Last Updated
December 5, 2012
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00634452
Brief Title
Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
Acronym
MDX1401-01
Official Title
A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Lymphomas
Keywords
Hodgkin's, Cancer, bi-measurable disease, 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
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MDX-1401
Arm Type
Experimental
Arm Description
MDX-1401 iv at various doses
Intervention Type
Biological
Intervention Name(s)
MDX-1401
Intervention Description
IV weekly for 4 weeks
Primary Outcome Measure Information:
Title
Safety and Tolerability Profile
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
Day 50
Title
Tumor response assessment
Time Frame
Two year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant Bi-measurable disease ECOG Performance Status of 0 - 2 Meet all screening laboratory values Exclusion Criteria: Previous treatment with any other anti-CD30 antibody History of allogeneic transplant Any tumor lesion greater than or equal to 10 cm in diameter Any active or chronic significant infection Underlying medical condition which will make the administration of MDX- 1401 hazardous Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
ClinWorks Cancer Research Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Scott and White Memorial Hospital and Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma

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