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Trial record 3 of 218 for:    1401

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00634452
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphomas Biological: MDX-1401 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2008
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MDX-1401
MDX-1401 iv at various doses
Biological: MDX-1401
IV weekly for 4 weeks


Outcome Measures

Primary Outcome Measures :
  1. Safety and Tolerability Profile [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Day 50 ]
  2. Tumor response assessment [ Time Frame: Two year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634452


Locations
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
ClinWorks Cancer Research Center
Charlotte, North Carolina, United States, 28207
United States, Texas
Scott and White Memorial Hospital and Clinic
Temple, Texas, United States, 76508
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00634452     History of Changes
Other Study ID Numbers: MDX1401-01
CA213-001 ( Other Identifier: BMS )
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

Keywords provided by Bristol-Myers Squibb:
Hodgkin's
Cancer
bi-measurable disease
Lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases