Status:
COMPLETED
RAD001 in Relapsed or Refractory AML, ALL, CML in Blastic-Phase, Agnogenic Myeloid Metaplasia, CLL, T-Cell Leukemia, or Mantle Cell Lymphoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Novartis
Conditions:
Leukemia
Mantle Cell Lymphoma
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical research study is to find the highest safe dose of RAD001 that can be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis. Another goal is to learn how ...
Detailed Description
RAD001 is a new drug that was designed to block proteins that are important in the development and growth of cancer. If you are eligible to take part in this study, you will receive treatment with RA...
Eligibility Criteria
Inclusion
- Patients with advanced, relapsed or refractory: acute leukemias (AML, ALL), MDS, CMML in transformation with greater than or equal to 10% peripheral blood/bone marrow blasts, CML in blastic phase, agnogenic myeloid metaplasia (AMM), CLL, T-cell leukemia, or mantle cell lymphoma.
- Serum bilirubin \<= 2 mg/dL, SGOT or SGPT \< 3 upper limit of normal, serum creatinine \<= 2 mg/dL, unless considered due to organ leukemic involvement or Gilbert's syndrome
- The effects of RAD001 on the developing human fetus are unknown. For this reason and because inhibitors of mRNA translation are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients who have had cytotoxic chemotherapy (other than hydroxyurea or corticosteroids) or radiotherapy within 7 days prior to entering the study.
- Patients may not be receiving any other cytotoxic investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001. RAD001 must not be administered to patients with known hypersensitivity to everolimus, sirolimus or to any of its excipients. Excipients include butylated hydroxytoluene, magnesium stearate, hydroxypropylmethyl-cellulose, crospovidone, and lactose.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because RAD001 has a potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with RAD001, breastfeeding should be discontinued if the mother is treated with RAD001.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00081874
Start Date
April 1 2004
End Date
September 1 2006
Last Update
April 27 2025
Active Locations (1)
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1
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030