Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I Study of GTI2040 (NSC 722929; IND 67368) in Combination With High-dose Cytarabine in Refractory or Relapsed Acute Myeloid Leukemia (AML)
Verified date | June 2013 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This phase I trial is studying the side effects and best dose of GTI-2040 and high-dose cytarabine in treating patients with refractory or relapsed acute myeloid leukemia. 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. Giving GTI-2040 together with cytarabine may kill more cancer cells.
Status | Completed |
Enrollment | 51 |
Est. completion date | |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - Performance status - ECOG 0-2 - At least 4 weeks - 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* - Creatinine no greater than 1.5 mg/dL* - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - Resting ejection fraction at least 50%* - 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 - More than 4 weeks since prior chemotherapy (except hydroxyurea) (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy - No concurrent hormonal therapy except steroids for adrenal failure and hormones for non-disease-related conditions (e.g., insulin for diabetes) - More than 4 weeks since prior radiotherapy - No concurrent palliative radiotherapy - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum-tolerated dose (MTD) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 | Up to day 42 | Yes | |
Secondary | Therapeutic response | Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data. | Up to 6 years | No |
Secondary | Change in R2 expression in circulating and marrow leukemia cells | Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data. | From baseline to up to 6 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01564277 -
Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
Completed |
NCT02484391 -
CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma
|
Phase 1 | |
Active, not recruiting |
NCT02204085 -
A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
Completed |
NCT01233921 -
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
|
N/A | |
Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
Terminated |
NCT00387426 -
Sunitinib in Treating Patients With Idiopathic Myelofibrosis
|
Phase 2 | |
Active, not recruiting |
NCT01056614 -
Fludarabine Phosphate, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Peripheral Blood Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Malignancies
|
Phase 2 | |
Completed |
NCT00093418 -
S0432 Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia
|
Phase 2 | |
Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
Terminated |
NCT00052598 -
Therapeutic Allogeneic Lymphocytes and Aldesleukin in Treating Patients With High-Risk or Recurrent Myeloid Leukemia After Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
Terminated |
NCT00049582 -
Decitabine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia
|
Phase 1 | |
Completed |
NCT00052520 -
Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
|
Phase 1/Phase 2 | |
Completed |
NCT01798901 -
AR-42 and Decitabine in Treating Patients With Acute Myeloid Leukemia
|
Phase 1 | |
Terminated |
NCT01876953 -
Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
Completed |
NCT02070458 -
Ixazomib, Mitoxantrone Hydrochloride, Etoposide, and Intermediate-Dose Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 1 | |
Completed |
NCT02583893 -
Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia
|
Phase 2 | |
Completed |
NCT01555268 -
Trebananib With or Without Low-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
|
Phase 1 | |
Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 |