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

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

This study is currently recruiting participants.

Verified by Medarex, August 2009

First Received: February 26, 2008 Last Updated: August 28, 2009 History of Changes

Sponsored by:	Medarex
Information provided by:	Medarex
ClinicalTrials.gov Identifier:	NCT00634452

Purpose

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

Condition	Intervention	Phase
Hodgkin's Lymphomas	Biological: MDX-1401	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma

U.S. FDA Resources

Further study details as provided by Medarex:

Primary Outcome Measures:

Safety and Tolerability Profile [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Objective Response Rate (ORR) [ Time Frame: Day 50 ] [ Designated as safety issue: No ]
Tumor response assessment [ Time Frame: Two year ] [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	February 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MDX-1401: Experimental MDX-1401 iv at various doses	Biological: MDX-1401 IV weekly for 4 weeks

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634452

Contacts

Contact: Medarex Medical Monitor

908-479-2400

Locations

United States, Georgia
Winship Cancer Institute, Emory University	Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Jonathan Kaufman, MD
United States, Illinois
Northwestern University Feinberg School of Medicine	Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Andrew Evens, DO
United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Principal Investigator: Steven Horwitz
United States, North Carolina
ClinWorks Cancer Research Center	Active, not recruiting
Charlotte, North Carolina, United States, 28207
United States, Texas
Scott and White Memorial Hospital and Clinic	Active, not recruiting
Temple, Texas, United States, 76508
United States, West Virginia
West Virginia University	Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Michael D Craig, MD 304-293-6859 craigm@rcbhsc.wvu.edu
Principal Investigator: Michael D Craig, MD

Sponsors and Collaborators

Medarex

Investigators

Study Director:

Medarex Medical Monitor

Medarex

More Information

No publications provided

Responsible Party:	Medarex Inc. ( Medarex Inc. )
Study ID Numbers:	MDX1401-01
Study First Received:	February 26, 2008
Last Updated:	August 28, 2009
ClinicalTrials.gov Identifier:	NCT00634452 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medarex:

Hodgkin's
Cancer
bi-measurable disease
Lymphoma

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Hodgkin's Disease

Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease

ClinicalTrials.gov processed this record on September 10, 2009