A Pilot Study to Determine the Safety and Tolerability of Sirolimus Given With Hyper-CVAD Chemoth… (NCT01184885) | Clinical Trial Compass
CompletedEarly Phase 1
A Pilot Study to Determine the Safety and Tolerability of Sirolimus Given With Hyper-CVAD Chemotherapy
United States7 participantsStarted 2010-07
Plain-language summary
This is a pilot study, assessing the feasibility, safety and toxicity of an mTOR (mammalian target of Rapamycin) inhibitor (MTI), rapamycin, when administered with HyperCVAD (Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicine and Dexamethasone), with an ultimate goal to perform a phase II study to evaluate response rates and survival in adults with Acute Lymphoblastic Leukemia (ALL) and aggressive lymphoid malignancies.
Who can participate
Age range
18 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
. Patients must have a diagnosis of one of the following lymphoid malignancies (new or relapsed):
. Patients must be \>18 years old
. Patients must have an ECOG performance status of 0 or 1(see attachment 1).
. Patients must have a life expectancy of at least 4 weeks.
. Patients must be able to consume oral medication.
. Patients must have completed any radiotherapy four weeks prior to study entry, 0-2 weeks for local palliative XRT (small port).
. Patients must have recovered from the toxic effects of any prior chemotherapy to \< grade 2 (except alopecia).
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
Number of Participants With Count Recovery That Allows for Starting a Phase II Study to Evaluate Response Rates and Survival
Timeframe: 18 months
Trial details
NCT IDNCT01184885
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
. Required initial laboratory values: Creatinine \< or = 2.0mg/dL; total or direct bilirubin \< or = 1.5mg/dL (if not due to the leukemia or lymphoma itself); SGPT(ALT) \< or = 3xULN; glucose \<200 mg/dL, negative pregnancy test for women with child-bearing potential.
Exclusion criteria
. Patients must not be receiving any chemotherapy agents (except Hydroxyurea)
. Intrathecal ARA-C and intrathecal methotrexate are permissible (as they are not systemic and only isolated to the central nervous system).
. Patients must not be receiving growth factors, except for erythropoietin.
. Patients with a current second malignancy requiring systemic therapy, other than non-melanoma skin cancers, are not eligible.
. Patients with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, myocardial infarction within the past 6 months or serious uncontrolled cardiac arrhythmia are not eligible.
. Patients taking any of the following drugs while on-study are not eligible: