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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.
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Inclusion criteria
Histologically proven lymphoproliferative neoplasm belonging to one of the following disease categories that has relapsed or has an incomplete response to conventional therapy, or where the patient is considered intolerant to conventional chemotherapy or where no other conventional therapy is considered appropriate.
The lymphoma needs to be accessible, convenient and safe (< 5% risk of bleeding or serious event) for biopsy in at least one of the following sample types on multiple occasions as stipulated by the study protocol:
Age ≥ 18 years
ECOG performance status score 0-2 at screening.
Life expectancy of ≥12 weeks
Patient has the following laboratory values within 3 weeks of starting study drug (labs may be repeated, if needed, to obtain acceptable values before failure at screening is concluded)
Patient has the ability to swallow capsules.
Sexually active patient (men and women of child bearing potential) agrees to use double barrier method of contraception during the course of the study treatment period (13 cycles) and for 3 months after completing study treatment. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who are not postmenapausal (no menses) for at least 12 consecutive months.
Males with a female partner of childbearing potential must agree to use a medically reliable method of preventing conception throughout the study and for 30 days following the date of last dose.
Mentally competent and is able to understand the information given and provide informed consent to both the clinical aspects of the study as well as the demands of the correlative studies and associated tumour biopsies.
Exclusion criteria
Concomitant use (within 28 days of first biopsy) of any anti-cancer therapy including radiation therapy
Exposure to a histone deacetylase inhibitor within the preceding 4 weeks.
Patient has received chemotherapy or any investigational drug or undergone major surgery ≤ 2 weeks prior to starting study drug or whose side effects of such therapy have not resolved to ≤ grade 1 (except for grade 2 neuropathy).
Current involvement (medication delivered within 28 days of first biopsy)in a study of an alternative investigational agent.
Impaired cardiac function including any one of the following:
Patient is taking medications with relative risk of prolonging the QT interval or inducing torsade de pointes, if such treatment cannot be discontinued or switched to a different medication prior to starting study drug
Patient has impairment of GI function or GI disease that may significantly alter the absorption of panobinostat, such as:
Known HIV, hepatitis B or hepatitis C (a screening test is not required)
Female patients who are pregnant or breast feeding
Other concurrent severe and/or uncontrolled medical conditions such as (but not limited to)
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
Prior diagnosis of cancer that was:
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30 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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