Hodgkin's Lymphoma
Conditions
Keywords
Relapsed or Refractory Hodgkin's Lymphoma, Phase II
Brief summary
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.
Interventions
DRUGMGCD0103
MGCD0103 administered orally three times per wek
Sponsors
Mirati Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate | 1 year (anticipated) |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | 1 year (anticipated) |
| Duration of objective response | 1 year (anticipated) |
| Safety profile | 1 year (anticipated) |
| Pharmacodynamics (biomarkers) | 1 year (anticipated) |
Countries
Canada, United States
Outcome results
None listed