Gamma-Secretase Inhibitor RO4929097 in Treating Young Patients With Relapsed or Refractory Solid … (NCT01088763) | Clinical Trial Compass
TerminatedPhase 1
Gamma-Secretase Inhibitor RO4929097 in Treating Young Patients With Relapsed or Refractory Solid Tumors, CNS Tumors, Lymphoma, or T-Cell Leukemia
United States, Canada129 participantsStarted 2010-03
Plain-language summary
This phase I/II clinical trial is studying the side effects and best dose of gamma-secretase inhibitor RO4929097 and to see how well it works in treating young patients with relapsed or refractory solid tumors, CNS tumors, lymphoma, or T-cell leukemia. Gamma-secretase inhibitor RO4929097 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range
1 Year – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed malignancy (at diagnosis or relapse)
* Biopsy not required for intrinsic brain stem tumors or optic pathway gliomas
* No B-cell precursor acute lymphoblastic lymphoma (ALL) or acute myeloid leukemia
* No T-cell leukemia with CNS3 disease
* Measurable or evaluable 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
* Neurologic deficits in patients with CNS tumors must have been relatively stable for 1 week
* No active CNS leukemia
* Karnofsky performance status (PS) 50-100% (for patients \> 16 years of age) or Lansky PS 50-100% (for patients ≤ 16 years of age)
* Patients who are unable to walk because of paralysis,but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the PS
* Patients with solid tumors without bone marrow involvement must meet the following criteria:
* Peripheral ANC ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions within the past 7 days)
* Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
* Patients with known bone marrow metastatic disease must meet the above criteria and must not be known to be refractory to red cell or platelet transfusion
* Patients with leukemia must meet the following criteria:
* Platelet count ≥ 20,000/mm\^3 (may receive platelet transfusions)
* Hemoglo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) of RO4929097 determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Timeframe: 28 days
2
MTD of RO4929097 administered with dexamethasone determined according to DLTs graded using CTCAE v4.0