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

Phase 2
18 Years
Not Enrolling
Hodgkin's Lymphoma

Thank you

Trial Information

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Success rate

Outcome Time Frame:

1 year (anticipated)

Safety Issue:


Principal Investigator

Gregory Reid, MSc, MBA

Investigator Role:

Study Director

Investigator Affiliation:

MethylGene Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

January 2009

Related Keywords:

  • Hodgkin's Lymphoma
  • Relapsed or Refractory Hodgkin's Lymphoma
  • Phase II
  • Hodgkin Disease
  • Lymphoma



MD Anderson Cancer Center Houston, Texas  77030-4096
Rush University Medical Center Chicago, Illinois  60612-3824
Nebraska Medical Center Omaha, Nebraska  68198