Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

This study has been terminated.
Sponsor:
Information provided by:
MethylGene Inc.
ClinicalTrials.gov Identifier:
NCT00358982
First received: July 31, 2006
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

MGCD0103 is an experimental drug that belongs to a class of drugs known as the histone deacetylase inhibitors, which may restore normal control in cancer cells by affecting the genes and proteins that are being made. Laboratory tests show that this new investigational anti-cancer drug can slow down the growth of human cancer cells in mice; two clinical research studies are currently being performed in humans with cancer and a similar study is being performed in patients with the same disease.

The purpose of this study is to find out what effect the experimental drug MGCD0103 has on patients with relapsed and refractory Hodgkin's lymphoma.


Condition Intervention Phase
Hodgkin's Lymphoma
Drug: MGCD0103
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by MethylGene Inc.:

Primary Outcome Measures:
  • Success rate [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: Yes ]
  • Duration of objective response [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: Yes ]
  • Pharmacodynamics (biomarkers) [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: August 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MGCD0103
MGCD0103 administered orally three times per wek

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologic confirmation of relapsed or refractory classical Hodgkin's lymphoma.
  • The patient has at least one site of measurable disease (≥ 2.0 cm) as measured by conventional techniques such as CT or MRI.
  • Prior treatment: there is no limit to number of prior therapies. Patients who had prior allogeneic stem cell transplants and do not have evidence of graft versus host disease and are not receiving immunosuppressive agents are eligible if they meet all other inclusion criteria.
  • ECOG performance status of 0 or 1.
  • Aged 18 years or older (no safety data yet for ages < 18).
  • Laboratory requirements (must be done within 7 days prior to study initiation).

Exclusion Criteria:

  • Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia [CIN/cervical in situ] or melanoma in situ). Prior history of cancer is allowed, as long as there is no active disease.
  • Pregnant or lactating women. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test documented within 7 days prior to start of study drug.
  • WOCBP and men whose partners are WOCBP must use an acceptable method of contraception while enrolled in this study, and for a period of 3 months following study drug treatment.
  • Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever > 38.5°C (not due to tumor fever) on the day of scheduled dosing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358982

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
MethylGene Inc.
Investigators
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
  More Information

No publications provided by MethylGene Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory Reid, Chief Medical Officer, MethylGene, Inc.
ClinicalTrials.gov Identifier: NCT00358982     History of Changes
Other Study ID Numbers: 0103-010
Study First Received: July 31, 2006
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by MethylGene Inc.:
Relapsed or Refractory Hodgkin's Lymphoma
Phase II

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
N-(2-aminophenyl)-4-((4-pyridin-3-ylpyrimidin-2-ylamino)methyl)benzamide
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014