Lymphoma Clinical Trial
Official title:
A Phase 1/2 Study of RO4929097, An Oral Small Molecule Inhibitor of Gamma-Secretase, in Children With Relapsed/Refractory Solid or CNS Tumors, Lymphoma, or T-Cell Leukemia
Verified date | April 13, 2011 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background:
- The anti-cancer drug RO4929097 is being tested for its ability to block blood vessel growth
to tumors and slow or stop the growth of cancer cells. However, it has been used in only a
small number of adults and has not yet been tested in children. Researchers are interested in
determining whether RO4929097 is a safe and effective treatment for tumors or leukemia that
has not responded to standard treatment.
Objectives:
- To determine the safety and effectiveness of RO4929097 as a treatment for children and
adolescents who have been diagnosed with certain kinds of cancer that have not responded to
standard treatment.
Eligibility:
- Children, adolescents, and young adults between 1 and 21 years of age who have been
diagnosed with solid, nervous system, or blood-based cancers that have not responded to
standard treatment.
Design:
- Participants will be screened with a medical history, physical examination, blood and
urine tests, and imaging studies. Some participants may also have a bone marrow biopsy
to evaluate the state of their disease.
- Participants will be separated into three groups: One group will receive RO4929097
alone, and the other two will receive RO4929097 in combination with the
immune-suppressing drug dexamethasone.
- RO4929097 will be given as tablets on one of two schedules: days 1 to 3 of every week
(Schedule A) or days 1 to 5 of every week (Schedule B). The dosing schedule will be
determined randomly. Every 4-week treatment period is one cycle, and participants may
receive RO4929097 for up to 24 cycles.
- Participants will have frequent blood and urine tests and imaging studies to evaluate
the progress of treatment, and will be asked to keep a diary to monitor any side
effects.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 13, 2011 |
Est. primary completion date | April 13, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 21 Years |
Eligibility |
- ELIGIBILITY CRITERIA: - Patients greater than 12 months and less than or equal to 21 years of age with a diagnosis and histologic verification (except patients with intrinsic brain stem tumors, optic pathway gliomas) of measureable or evaluable relapsed or refractory disease. Current disease state must be one for which there is no known curative therapy, or therapy proven to prolong survival with an acceptable quality of life. - Subjects must be able to swallow tablets. - Patients who are pregnant, are known to be serologically positive for Hepatitis A, B, C, or have a history of liver disease, or have prolonged QTc are not eligible. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
United States | St. Jude Childrens Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Artavanis-Tsakonas S, Rand MD, Lake RJ. Notch signaling: cell fate control and signal integration in development. Science. 1999 Apr 30;284(5415):770-6. Review. — View Citation
Bray SJ. Notch signalling: a simple pathway becomes complex. Nat Rev Mol Cell Biol. 2006 Sep;7(9):678-89. Review. — View Citation
Curry CL, Reed LL, Golde TE, Miele L, Nickoloff BJ, Foreman KE. Gamma secretase inhibitor blocks Notch activation and induces apoptosis in Kaposi's sarcoma tumor cells. Oncogene. 2005 Sep 22;24(42):6333-44. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcomes of this study are self-reported fatigue, depression, and quality of life scores of patients before, at midpoint, and at completion of each cycle of their cancer treatment. | |||
Secondary | Cytokine profile |
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