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Home > "G" Clinical Trials Conditions > GTI-2040 and High-Dose Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia  GTI-2040 and High-Dose Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
GTI-2040 and High-Dose Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
For Condition: recurrent adult acute myeloid leukemia
Status: Recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: GTI-2040 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining GTI-2040 with cytarabine may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining GTI-2040 with high-dose cytarabine in treating patients who have refractory or relapsedacute myeloid leukemia.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose and recommended phase II dose of GTI-2040 and high-dose cytarabine in patients with relapsed or refractory acute myeloid leukemia. Secondary - Determine the therapeutic response in patients treated with this regimen. - Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients are stratified according to age (under age 60 vs age 60 and over). Patients are assigned to 1 of 2 strata. - Stratum I (under age 60): Patients receive GTI-2040 IV continuously on days 1-7 and high-dose cytarabine IV over 2 hours twice daily on days 2-7. - Stratum II (age 60 and over): Patients receive GTI-2040 IV continuously on days 1-6 and high-dose cytarabine IV over 4 hours once daily on days 2-6. In both strata, treatment continues in the absence of unacceptable toxicity. Cohorts of 3-6 patients per stratum receive escalating doses of GTI-2040 and high-dose cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 6-33 patients will be accrued for this study within 2-16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed acute myeloid leukemia according to the WHO classification - Relapsed or refractory disease, meeting 1 of the following criteria: - Unresponsive to initial treatment - Recurrent disease after treatment with prior conventional or high-dose chemotherapy with or without stem cell support - CNS involvement allowed provided there are no residual leukemic cells detected in the cerebrospinal fluid after intrathecal or radiation chemotherapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 4 weeks Hematopoietic - Not specified Hepatic - Bilirubin no greater than 2 times upper limit of normal* (ULN) (unless due to Gilbert's syndrome) - AST and ALT no greater than 3 times ULN* NOTE: *Unless directly attributable to the malignancy Renal - Creatinine no greater than 1.5 mg/dL* NOTE: *Unless directly attributable to the malignancy Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - Resting ejection fraction at least 50%* NOTE: *Unless directly attributable to the malignancy Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergy to study medications - No ongoing or active infection requiring IV antibiotics - No other concurrent uncontrolled illness - No serious medical or psychiatric illness that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy (except hydroxyurea) (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy except steroids for adrenal failure and hormones for non-disease-related conditions (e.g., insulin for diabetes) Radiotherapy - More than 4 weeks since prior radiotherapy - No concurrent palliative radiotherapy Surgery - Not specified Other - Prior therapy with antisense oligonucleotides allowed provided no toxic effects were experienced that were directly attributable to the antisense agents - No other concurrent investigational agents - No other concurrent anticancer therapy - No concurrent chronic systemic anticoagulant therapy for medical conditions (e.g., prior deep vein thrombosis or atrial fibrillation) - Concurrent heparin to maintain central line patency (i.e., catheter flush) is allowed - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GuidoMarcucci, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Guido Marcucci 614-293-7597
Additional Information:
Study ID Numbers: CDR0000334898; OSU-0304,NCI-6108,OSU-20030030
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070551
Other Recurrent Adult Acute Myeloid Leukemia Studies:
1. Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia
2. Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
3. BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
4. Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
5. Monoclonal Antibody in Treating Patients With Acute Myelogenous Leukemia
Related Studies:
Other recurrent adult acute myeloid leukemia Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
GTI-2040 and High-Dose Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
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