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Panobinostat Biological Correlates Study

NCT01658241 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Nodal Lymphoma
  • Lymphoma With Cutaneous Involvement
  • Lymphoma in Leukemic Phase
  • Marrow Involvement With Lymphoma
  • Multiple Myeloma

Interventions

DRUG

panobinostat

40mg, three times a week, oral pill over 12 cycles, 4 weeks per cycle

Sponsors & Collaborators

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Michael Dickinson · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-16
Primary Completion
2015-03-18
Completion
2015-03-18

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01658241 on ClinicalTrials.gov