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 range18 Years
SexALL
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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).
✓. 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.
✕
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
. 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: