Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase 1 Study of Vorinostat (Suberoylanilide Hydroxamic Acid; SAHA) in Combination With Decitabine in Patients With Advanced Solid Tumors, Relapsed or Refractory Non-Hodgkin's Lymphoma, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Chronic Myelogenous Leukemia in Blast Crisis
This phase I trial is studying the side effects and best dose of vorinostat when given
together with decitabine in treating patients with advanced solid tumors or relapsed or
refractory non-Hodgkin's lymphoma, acute myeloid leukemia, acute lymphocytic leukemia, or
chronic myelogenous leukemia.
Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for
cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop
the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Giving vorinostat together with decitabine may kill more cancer cells.
PRIMARY OBJECTIVES:
I. Establish the maximum tolerated dose and recommended phase II dose of vorinostat in
conjunction with decitabine in patients with advanced solid tumors or relapsed or refractory
non-Hodgkin's lymphoma, acute myeloid leukemia, acute lymphocytic leukemia, or chronic
myelogenous leukemia in blast crisis.
SECONDARY OBJECTIVES:
I. Identify the minimal effective dose of vorinostat in conjunction with decitabine that
will lead to DNA demethylation, histone acetylation, and gene reactivation with tolerable
toxicity in these patients.
II. Determine the pharmacokinetic profiles of vorinostat and decitabine in these patients.
Correlate pharmacokinetic profiles of vorinostat and decitabine with toxicity and biological
activity in these patients.
III. Assess the antitumor activity of vorinostat and decitabine in these patients.
OUTLINE: This is a parallel group, multicenter, dose-escalation study of vorinostat.
Patients are stratified according to disease (solid tumors or non-Hodgkin's lymphoma [NHL]
vs hematological malignancies).
Patients receive 1 of 2 dosing regimens.
Regimen 1 (sequential dosing): Patients receive oral vorinostat two or three times daily on
days 6-21 or days 6-12 (patients with solid tumors or NHL only) and decitabine IV over 1
hour on days 1-5. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
Regimen 2 (concurrent dosing): Patients receive oral vorinostat two or three times daily on
days 1-21, days 1-14 (patients with hematological malignancies only), or two times daily on
days 1-12 (patients with solid tumors or NHL only) and decitabine IV over 1 hour on days
1-5.
Courses repeat every 28 days or 21 days (patients with hematological malignancies only) in
the absence of disease progression or unacceptable toxicity. In both groups, cohorts of 3-6
patients receive escalating doses of vorinostat until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients
experience dose-limiting toxicity. The dose level just below MTD would be declared the
recommended phase II dose (RPTD). Up to 10 patients are treated at the RPTD. After
completion of study treatment, patients are followed at 4 weeks.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01828775 -
Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
|
N/A | |
| Terminated |
NCT01642342 -
Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00002950 -
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01705548 -
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
|
N/A | |
| Completed |
NCT02146222 -
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors
|
Phase 1 | |
| Terminated |
NCT01602627 -
Hsp90 Inhibitor AUY922 in Treating Older Patients With Advanced Solid Malignancies
|
Phase 1 | |
| Completed |
NCT01191216 -
1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT01137825 -
Registry of Older Patients With Cancer
|
||
| Recruiting |
NCT00992303 -
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
|
||
| Completed |
NCT00949949 -
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
|
Phase 1 | |
| Completed |
NCT00924651 -
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
|
Phase 3 | |
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Withdrawn |
NCT00937417 -
S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT00710632 -
Screening to Predict Weight Loss in Patients With Cancer
|
N/A | |
| Completed |
NCT00573690 -
Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00544596 -
R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT00436735 -
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00352443 -
S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00128622 -
Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT00121277 -
Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 |