Panobinostat Biological Correlates Study (VEG VCA1)
|ClinicalTrials.gov Identifier: NCT01658241|
Recruitment Status : Active, not recruiting
First Posted : August 6, 2012
Last Update Posted : September 20, 2017
This study is looking at the effects of Panobinostat, an investigational treatment, on cancer cells in patients who have Hodgkin lymphoma (a cancer of the immune system with specific Hodgkin/Reed Sternberg Cells), T-cell lymphoma (a cancer of the immune system with too many T lymphocytes), chronic lymphocytic leukemia or prolymphocytic leukaemia (immune system with too many lymphocytes in the blood stream), lymphoplasmacytic lymphoma (immune system with too many plasma cells or B lymphocytes) or myeloma (a cancer of plasma cells).
Panobinostat is a new drug which has led to disease improvement in some patients with Hodgkin lymphoma, certain types of T-cell lymphoma, myeloma and some B cell lymphomas. Not all patients benefit from panobinostat.
The researchers wish to look at the effects of panobinostat on cancer cells. The aim of this project is find out which patients or diseases are likely to respond to treatment with panobinostat in the future and to see if there are particular features of the patient or of the cancer that affects the likelihood of the way individuals respond to panobinostat.
Panobinostat is an oral medication (taken by mouth) that effects the way cancer cells and in normal cells make proteins. Panobinostat has been used in several clinical trials around the world. The largest trials generally have fewer than 200 patients and are in Hodgkin lymphoma, cutaneous T-cell lymphoma, and myeloma where between one in five and one in three patients have significant improvement in their disease.
Researchers will look at samples of tumour before treatment and during treatment. This will be one of the first studies to look at how cancer cells change following treatment with this drug. It is unusual because it requires repeated biopsies of the participant's tumour. Panobinostat is considered an experimental (or investigational) drug and not approved by any regulatory authority (such as the Food and Drug Administration, FDA in the USA or by the Therapeutics Goods and Administration, TGA, in Australia) to treat any type of cancer. Therefore, Panobinostat is not approved to treat patients who have been diagnosed with refractory or relapsed cancer.
A total of 30 patients with one of the diseases listed above will be enrolled at Peter MacCallum Cancer Centre.
It is expected it will take about 2 to 3 years to recruit 30 patients and that on average patients will take part for six to eighteen months. This time could be shorter or longer depending on how well the treatment works in each individual. While the trial will take up to 4 years to complete, the science studies may take longer.
|Condition or disease||Intervention/treatment||Phase|
|Nodal Lymphoma Lymphoma With Cutaneous Involvement Lymphoma in Leukemic Phase Marrow Involvement With Lymphoma Multiple Myeloma||Drug: panobinostat||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase II Study to Investigate Biological Correlates of Clinical Response to Panobinostat in Haematological Malignancy|
|Study Start Date :||July 2012|
|Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2018|
|Experimental: Single Arm Main population||
40mg, three times a week, oral pill over 12 cycles, 4 weeks per cycle
Other Name: LBH589
- Change in gene expression profile of tumor samples taken before and after treatement with panobinostat [ Time Frame: Up to two years from trial entry ]
- Overall response (OR): this is a composite clinical endpoint including those who have achieved a complete remission (CR) or partial remission (PR) by conventional disease-appropriate criteria. (i.e. OR=CR+PR) [ Time Frame: Up to two years from trial entry ]
- Clinical benefit: a composite endpoint including those with complete remission, partial remission, marginal response and those with otherwise stable disease that has been maintained for at least 2 cycles of therapy [ Time Frame: Up to two years from trial entry ]
- Time to response: the time from first drug dose to best confirmed response [ Time Frame: Up to two years from trial entry ]
- Time to progression: the time from initial observation of response to confirmed disease progression, or the time from first drug dose to confirmed disease progression [ Time Frame: Up to two years from trial entry ]
- Progression-free survival: time from trial registration to disease progression or death from any cause [ Time Frame: Up to two years from trial entry ]
- Disease-specific biological improvement - as defined in the protocol [ Time Frame: Up to two years from trial entry ]
- Sustained disease-specific biological improvement - as defined in the protocol [ Time Frame: Up to two years from trial entry ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658241
|Peter MacCallum Cancer Centre|
|Melbourne, Victoria, Australia, 3002|
|Principal Investigator:||Michael Dickinson||Peter MacCallum Cancer Centre, Australia|