Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00276601
First received: January 12, 2006
Last updated: October 1, 2010
Last verified: October 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy works in treating patients with acute promyelocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: arsenic trioxide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: mercaptopurine Drug: methotrexate Drug: tretinoin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Arsenic Trioxide-Based Consolidation Therapy for the Primary Treatment of Acute Promyelocytic Leukemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
acute promyelocytic leukemia
familial acute myeloid leukemia with mutated CEBPA
Drug Information available for:
Mercaptopurine
Methotrexate
Cytarabine
Tretinoin
Arsenic trioxide
Arsenic
Methotrexate sodium
Daunorubicin
Daunorubicin hydrochloride
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:
Primary Outcome Measures:
- Disease-free survival at 2 and 5 years after study completion [ Designated as safety issue: No ]
- Safety of arsenic trioxide following cytarabine and anthracycline immediately after study completion [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Validate peripheral blood real-time PCR for minimal disease monitoring as measured by real-time PCR for PML-RARalpha monthly for two years after study completion [ Designated as safety issue: No ]
| Study Start Date: | October 2004 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine, preliminarily, the safety of incorporating arsenic trioxide (ATO) into cytarabine and daunorubicin hydrochloride-based consolidation therapy followed by tretinoin maintenance therapy in patients receiving induction tretinoin and daunorubicin hydrochloride with acute promyelocytic leukemia (APL) induced into remission with tretinoin and daunorubicin hydrochloride.
- Determine, preliminarily, the efficacy of this strategy in inducing and maintaining molecular remissions in patients treated with this regimen.
OUTLINE: This is a pilot, multicenter study.
- Induction therapy: Patients receive oral tretinoin twice daily on days 1-60 and daunorubicin hydrochloride IV on days 4, 6, and 8. Patients are evaluated between days 60-67 and proceed to consolidation therapy.
- Consolidation therapy: Patients receive cytarabine IV continuously on days 1-3, daunorubicin hydrochloride IV on days 1-3, and arsenic trioxide IV over 1-2 hours once daily, 5 days a week, beginning on day 8 and continuing for 6 weeks. Patients with clinical and/or cytogenic, but not molecular, remission receive additional arsenic trioxide once daily, 5 days a week, for 30 doses (6 weeks). Patients achieving clinical and molecular remission after completion of 6 or 12 weeks of arsenic trioxide proceed to maintenance therapy.
- Maintenance therapy: Patients receive oral tretinoin once daily on days 1-15. Treatment repeats every 3 months for 8 courses (2 years).
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 5 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of acute promyelocytic leukemia (APL) by morphologic and flow cytometric documentation (high orthogonal light scatter, lack of HLA-DR expression)
Patients with classical APL as well as the microgranular variant (M3V) are eligible
- In cases where the diagnosis is unclear, consultation with a hematopathologist is required before enrolling the patient in the study
- Patients found to have cytogenetic abnormalities that do not produce the PML-RARα gene rearrangement will be removed from study and will not be included in data analysis
PATIENT CHARACTERISTICS:
- Patients will not be excluded because of performance status or comorbid disease
- Premenopausal female patients must have a negative pregnancy test
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for APL except hydroxyurea
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276601
Locations
| United States, Alabama | |
| Comprehensive Cancer Center at University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Florida | |
| University of Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610-0232 | |
| United States, Georgia | |
| Blood and Marrow Transplant Group of Georgia | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Nebraska | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| United States, Pennsylvania | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
| Study Chair: | Steven D. Gore, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Steven D. Gore, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| ClinicalTrials.gov Identifier: | NCT00276601 History of Changes |
| Other Study ID Numbers: | J0442, CDR0000449985, P30CA006973, JHOC-J0442, WIRB-20041058 |
| Study First Received: | January 12, 2006 |
| Last Updated: | October 1, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
untreated adult acute myeloid leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies adult acute promyelocytic leukemia (M3) childhood acute promyelocytic leukemia (M3) adult acute myeloid leukemia with t(15;17)(q22;q12) |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Promyelocytic, Acute Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid, Acute Leukemia, Myeloid 6-Mercaptopurine Cytarabine Methotrexate Arsenic trioxide Daunorubicin Tretinoin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Antiviral Agents Anti-Infective Agents Antibiotics, Antineoplastic Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013