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