Clinical trial NCT00359086: Study of MGCD0103 Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
Official title: A Phase II Study of MGCD0103 (MG-0103) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Relapsed and Refractory Lymphoma
Phase II
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with relapsed and refractory lymphoma.


Eligibility criteria: Inclusion Criteria:

* Pathologic confirmation of relapsed or refractory lymphoma.

  1. DLBCL stage II-IV
  2. Follicular lymphoma
* At least one site of measurable disease (≥ 2.0 cm with conventional techniques; physical exam \[PE\], CT, X-ray, MRI).
* Prior treatment:

  1. DLBCL cohort: Disease progression following initial therapy and transplant (unless the patient is ineligible or refused transplant). There is no limit to number of prior therapies.
  2. Follicular lymphoma cohort: Follicular lymphoma that is relapsed following or refractory to standard therapy and/or existing therapies or are not eligible for or are unlikely to achieve clinical benefit from those therapies. Patients must have failed 3 or more prior therapies.
* Must have at least one of the following considered related to disease:

  1. Local symptoms due to progressive or bulky nodal disease.
  2. Compromise of normal organ function due to progressive or bulky disease.
  3. Presence of systemic B symptoms.
  4. Presence of symptomatic extranodal disease.
  5. Cytopenias due to extensive bone marrow infiltration, autoimmune hemolytic anemia or thrombocytopenia, or hypersplenism.
* ECOG performance status of 0 or 1.
* Aged 18 years or older.
* Laboratory requirements.

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.
* Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever \>38.5 Celsius (not due to tumor fever) on the day of scheduled dosing.
* Patients with a history of pericardial disease.
* Patients with small, moderate or large pericardial effusions or patients with a diagnosis of pericarditis.
* Patients with significant cardiac abnormalities.
* Patients with serious illnesses, medical conditions, or other medical history which would be likely to interfere with patient's participation in the study or with the interpretation of the results.
* Patients who have been treated with any investigational drug within 28 days prior to study initiation.
* Known hypersensitivity to HDAC inhibitors and to any components of MGCD0103.
* Known human immunodeficiency virus (HIV) or active Hepatitis B or C.
* Central nervous system lymphoma and lymphoma involving leptomeningeal area.

Primary outcomes:
measure: Response rate
timeFrame: 1 year (anticipated)
Secondary outcomes:
measure: Progression-free survival
timeFrame: 1 year (anticipated)
measure: Duration of objective response
timeFrame: 1 year (anticipated)
measure: Safety profile
timeFrame: 1 year (anticipated)
measure: Pharmacokinetics
timeFrame: 1 year (anticipated)
measure: Pharmacodynamics
timeFrame: 1 year (anticipated)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Adult Bone Marrow Transplant Clinic
state: North Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Ottawa
country: Canada
facility: Ottawa Hospital - General Campus
state: Ontario
city: Greenfield Park
country: Canada
facility: Charles LeMoyne Hospital
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer Davis-Jewish General Hospital
state: Quebec
Study officials:
affiliation: MethylGene Inc.
name: Gregory Reid, MSc, MBA
role: STUDY_DIRECTOR
References: