Non Hodgkin Lymphoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

51

Study ID:

NCT00358982

Recruitment Status:

Terminated

Sponsor:

Mirati Therapeutics Inc.

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There are 5 Locations for this study

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Rush University Medical Center
Chicago Illinois, 60612, United States
Nebraska Medical Center
Omaha Nebraska, 68198, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Royal Victoria Hospital
Montreal Quebec, H3A 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

51

Study ID:

NCT00358982

Recruitment Status:

Terminated

Sponsor:


Mirati Therapeutics Inc.

How clear is this clinincal trial information?

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