View Clinical Trial (Medical Research Study)
A Phase I/II Study of the Histone Deacetylase (HDAC) Inhibitor LBH589 (Panobinostat) in Combination With mTOR Inhibitor RAD001 (Everolimus) in Patients With Relapsed Multiple Myeloma or Lymphoma
| City: |
|
Rochester |
| State: |
|
Minnesota |
| Zip Code: |
|
55905 |
| Conditions: |
|
Multiple Myeloma |
| Purpose: |
|
Background:
- Panobinostat and everolimus are experimental drugs to treat multiple myeloma. They help
block some of the chemical signals that encourage tumor cells to grow and function.
Researchers think that these drugs might be able to prevent the cancer cells from growing or
cause them to die. However, more tests are needed to determine the most effective dose of
these drugs.
Objectives:
- To test the effectiveness of panobinostat and everolimus for multiple myeloma or lymphoma.
Eligibility:
- Individuals at least 18 years of age who have multiple myeloma or lymphoma that has not
responded to standard treatments.
Design:
- Participants will be screened with a medical history, physical exam, blood and urine
tests, and bone marrow studies.
- Participants will have up to 12 cycles of treatment. Each cycle is 28 days.
- Participants will have everolimus daily and panobinostat on days 1, 3, 5, 15, 17 and
19.
- Participants will have frequent blood and bone marrow tests and imaging studies. After
two cycles, those whose cancer has improved or stayed the same and are tolerating the
treatment may have up to 10 more treatment cycles....
|
| Study Summary: |
|
Background:
- Multiple myeloma (MM) is a plasma cell malignancy characterized by bone destruction,
anemia, hypercalcemia, and renal failure that affects about 16,000 individuals and
results in nearly 12,000 deaths in the United States each year
- HDAC inhibitors have shown promising in vitro efficacy in the setting of myeloma and
the early phase clinical trials have been completed.
- LBH589 (Panobinostat) is a new chemical entity that is a potent inhibitor of DAC and
HSP90 belonging to a structurally novel class of the cinnamic hydroxamic acid class of
compounds, and is formulated as an oral capsule (LBH589B) and a solution for IV
injection (LBH589A)
- RAD001 (Everolimus) is a novel macrolide derivative of rapamycin formulated for oral
administration, which is being developed as an anti-proliferative drug with
applications as an immunosuppressant and anticancer agent.
- We hypothesize that a combination of RAD001 and LBH589 will have significant tumor
activity in myeloma both due to the direct anti-myeloma effect as well as indirectly
due to the powerful anti-angiogenic effect of the combination.
Objectives:
- To evaluate the therapeutic activity of the combination of LBH589 with RAD001 in
patients with relapsed or refractory multiple myeloma
- To further describe the toxicities associated with the combination of LBH589 with
RAD001
- To evaluate overall survival, progression-free survival, and duration of response
Eligibility:
- Age greater than or equal to 18 years.
- Relapsed or refractory multiple myeloma requiring therapy, who have failed, unable to
tolerate, or refused other available active therapies.
- Measurable disease as defined by at least ONE of the following:
- Serum monoclonal protein greater than or equal to 1.0 g/dL
- Greater than or equal to 200 mg of monoclonal protein in the urine on 24 hour
electrophoresis
- Serum immunoglobulin free light chain greater than or equal to 10 mg/dL AND
abnormal serum immunoglobulin kappa to lambda free light chain ratio.
- Monoclonal bone marrow plasmacytosis greater than or equal to 30% (evaluable
disease) at time of registration.
- ECOG performance status less than or equal to 2.
- Life expectancy greater than or equal to 12 weeks.
Study Design:
- NCI will only be participating in the Phase II portion of the study and will only
enroll patients in the Multiple Myeloma Arm.
- LBH589 will be administered orally (capsule formulation) 3 times weekly
- RAD001 will be administered orally (capsule formulation) daily.
- A cycle is defined as 28 days.
- For patients who have stable disease or PR, treatment may continue for 12 cycles.
|
| Criteria: |
|
- ELIGIBILITY CRITERIA:
- Age greater than or equal to 18 years.
- Relapsed or refractory multiple myeloma requiring therapy, who have failed, unable to
tolerate, or refused other available active therapies.
- Measurable disease as defined by at least ONE of the following:
- Serum monoclonal protein greater than or equal to 1.0 g/dL
- Greater than or equal to 200 mg of monoclonal protein in the urine on 24 hour
electrophoresis
- Serum immunoglobulin free light chain greater than or equal to 10 mg/dL AND
abnormal serum immunoglobulin kappa to lambda free light chain ratio.
- Monoclonal bone marrow plasmacytosis greater than or equal to 30% (evaluable
disease) at time of registration.
- ECOG performance status less than or equal to 2.
- Life expectancy greater than or equal to 12 weeks.
|
| NCT ID: |
|
NCT01417559 |
| Primary Contact: |
|
NCI Referral Office
Phone: 1-888-NCI-1937
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Rochester, Minnesota 55905
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 23, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|