Phase II Randomized Study of Two Different Schedules of Intravenous Clofarabine in Myelodysplastic Syndrome (MDS)
N/A
N/A
Both
Myelodysplastic Syndrome, Leukemia
Trial Information
Phase II Randomized Study of Two Different Schedules of Intravenous Clofarabine in Myelodysplastic Syndrome (MDS)
Clofarabine is a new chemotherapy drug that is designed to interfere with the growth and
development of cancer cells.
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to one of two treatment groups (Groups A and B). Participants in
Group A will receive a lower dose of clofarabine. Participants in Group B will receive a
higher dose of clofarabine. At first, there will be an equal chance of being assigned to
either group. However, as experience increases and more information becomes available, the
chance of being assigned to the group that has shown the most effectiveness will increase.
You and the study doctor will know to which group you are assigned.
Participants will receive clofarabine as a 1-hour infusion into a vein once a day for 5 days
in a row. This will be repeated every 4 to 8 weeks. Each 4-8 week period is considered 1
cycle of treatment.
For participants in both groups, after each cycle of therapy, they will not receive the next
cycle of chemotherapy until their blood counts have recovered and any possible side effects
have gone away (for around 4 to 8 weeks). You must stay in Houston for the first treatment
cycle (about 4 to 8 weeks) and will be required to return to Houston before receiving each
additional cycle of chemotherapy (up to 6 days each cycle).
Before every treatment cycle, your doctor will perform a physical exam, including
measurement of your weight and vital signs (blood pressure, heart rate, temperature, and
breathing rate). You will be asked about the level of your daily activities and how you are
feeling. You will have blood samples (about 1-2 teaspoons) collected for routine lab tests
1-2 times a week for the first cycle, then every 2-4 weeks while on therapy. Repeat bone
marrow samples will be collected every 1-3 cycles. However, if you complete the study before
the third cycle, the bone marrow may be taken then. You may choose to have check-up visits
and blood tests with your local doctor.
If you show a response and do not experience any severe side effects, you can receive up to
a total of 12 cycles of therapy. During each cycle, clofarabine will be given the same way
as during the first cycle. However, the dose of clofarabine may be lowered during later
cycles to decrease the risk of side effects that may have occurred in previous cycles. If
the disease gets worse or you experience any intolerable side effects, you will be taken off
the study and your doctor will discuss other treatment options with you.
This is an investigational study. Clofarabine is approved by the FDA for treatment of
pediatric acute lymphoblastic leukemia. Its use in this study is experimental. Up to 60
participants will take part in this study. All will be enrolled at M. D. Anderson.
Inclusion Criteria:
1. Patients with MDS and >/= 5% blasts or International Prognostic Scoring System (IPSS)
risk intermediate or high; patients with Chronic Myelomonocytic Leukemia (CMML).
2. No prior intensive chemotherapy or high-dose ara-C (> 1g/m2).
3. Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.
4. Patients must have been off chemotherapy for 2 weeks prior to entering this study and
recovered from the toxic effects of that therapy, unless there is evidence of rapidly
progressive disease.
5. Hydroxyurea is permitted for control of counts prior to treatment.
6. Procrit, GCSF are allowed before therapy.
7. Performance 0-2 (Eastern Cooperative Oncology Group (ECOG)). Adequate organ function
including the following: Adequate liver function (bilirubin of < 2mg/dl), and renal
function (creatinine < 2mg/dl), and SGPT (ALT) < 3 * upper limit of normal (ULN).
Adequate cardiac functions (New York Heart Association (NYHA) cardiac III-IV
excluded).
8. Signed informed consent.
Exclusion Criteria:
1. Nursing and pregnant females. Patients of childbearing potential should practice
effective methods of contraception. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately.
2. Active and uncontrolled infections.
3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or
psychiatric illness/social situations that would limit compliance with study
requirements.
4. Prior clofarabine treatment.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Response for Two Dose Schedules of Clofarabine
Outcome Description:
Response defined as Complete Remission (CR): Normalization of blood counts with neutrophils >/= 1 * 10^9/L and platelet counts >/= 100 * 10^9/L, and marrow blasts /= 100 * 10^9/L. Repeat bone marrow samples collected every 1-3 cycles (4-8 week cycle).
Outcome Time Frame:
4 weeks (minimum 1 cycle) up to 24 weeks (maximum 3 cycles of 8 weeks)
Safety Issue:
No
Principal Investigator
Hagop Kantarjian, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2005-0535
NCT ID:
NCT00422032
Start Date:
January 2006
Completion Date:
November 2011
Related Keywords:
- Myelodysplastic Syndrome
- Leukemia
- Myelodysplastic Syndrome
- Leukemia
- Clofarabine
- MDS
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
