ABT-751 With Chemotherapy for Relapsed Pediatric ALL
Overview[ - collapse ][ - ]
| Purpose | This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study. |
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| Condition | Recurrent Pediatric ALL Relapsed Pediatric ALL Acute Lymphoblastic Leukemia Refractory Pediatric ALL |
| Intervention | Drug: ABT-751 Drug: dexamethasone Drug: PEG-asparaginase Drug: doxorubicin Drug: cytarabine Drug: methotrexate Drug: cyclophosphamide Drug: 6-thioguanine |
| Phase | Phase 1 |
| Sponsor | Therapeutic Advances in Childhood Leukemia Consortium |
| Responsible Party | Therapeutic Advances in Childhood Leukemia Consortium |
| ClinicalTrials.gov Identifier | NCT00439296 |
| First Received | February 21, 2007 |
| Last Updated | November 28, 2012 |
| Last verified | November 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 21, 2007 |
|---|---|
| Last Updated Date | November 28, 2012 |
| Start Date | May 2006 |
| Estimated Primary Completion Date | September 2009 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | ABT-751 With Chemotherapy for Relapsed Pediatric ALL |
|---|---|
| Official Title | A Phase I/II Trial of ABT-751 Combined With Dexamethasone, PEG-asparaginase, and Doxorubicin in Relapsed Acute Lymphoblastic Leukemia (ALL) |
| Brief Summary | This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study. |
| Detailed Description | All patients will receive the 2 courses of chemotherapy unless medical complications prevent the administration of some of the drugs. Treatment for the first 2 courses of therapy will last about 2 months. Treatment on this study will consist of a combination of 8 anti-cancer medications. The 8 anticancer medicines are ABT-751, dexamethasone, PEG-asparaginase, doxorubicin, cytarabine (Ara-C), methotrexate (MTX), cyclophosphamide, and 6-thioguanine. All the drugs except ABT-751 are well known anti-cancer drugs and have been used extensively in the treatment of cancer. During the Phase I portion of this study, when you enroll, you will be given an assigned dose of ABT-751. The dose of ABT-751 will be based on doses given in previous studies done with adults and children. At each dose level of ABT-751, between 3 and 6 children will receive ABT-751 in combination with chemotherapy. If the side effects are not too severe, the next group of children will receive a higher dose. The dose will continue to be increased until we find the dose that causes serious side effects. Your dose of ABT-751 will not be increased. If you have bad side effects, your dose may be decreased. The dose used during the Phase 2 part of this study will be determined by the outcome of the Phase I study. The highest dose used in Phase I that was tolerated without serious side effects will be the one used in Phase 2. |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: ABT-751 Oral capsule to be given daily for 21 days. Drug: dexamethasone IV or Oral daily for 14 days Drug: PEG-asparaginase Intramuscular injection Drug: doxorubicin IV infusion Drug: cytarabine Intrathecal dose on day 1 Drug: methotrexate Intrathecal dose Drug: cyclophosphamide Intravenous dose Drug: 6-thioguanine Oral dose, course #2 |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 9 |
| Estimated Completion Date | September 2009 |
| Estimated Primary Completion Date | June 2009 |
| Eligibility Criteria | This is an abbreviated list... Inclusion Criteria: - Patients must be less than 21 years of age to be participate in this study. - Patients must have relapsed acute lymphoblastic leukemia (ALL) without evidence of central nervous system (CNS) disease. - Patients must have adequate kidney, heart and liver function. - Must be able to swallow capsules. Exclusion Criteria: - Patients who are pregnant or breast feeding. - Patients who have an allergy to Asparaginase products or sulfa-containing medications. - Patients who have an active uncontrolled infection. - Patients who have numbness or tingling in the hands or feet or constipation. |
| Gender | Both |
| Ages | N/A |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00439296 |
|---|---|
| Other Study ID Numbers | T2005-001 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Therapeutic Advances in Childhood Leukemia Consortium |
| Study Sponsor | Therapeutic Advances in Childhood Leukemia Consortium |
| Collaborators | Not Provided |
| Investigators | Study Chair: Paul S Gaynon, MD Childrens Hospital Los Angeles, Therapeutic Advances in Childhood Leukemia Consortium |
| Verification Date | November 2012 |
Locations[ + expand ][ + ]
| City of Hope | Duarte, California, United States, 91010 |
|---|---|
| Childrens Hospital Los Angeles | Los Angeles, California, United States, 90027 |
| Stanford University Medical Center | Palo Alto, California, United States, 94304-1812 |
| UCSF School of Medicine | San Francisco, California, United States, 94143-0106 |
| University of Miami Cancer Center | Miami, Florida, United States, 33136 |
| C.S. Mott Children's Hospital | Ann Arbor, Michigan, United States, 48109-0914 |
| Childrens Hospital & Clinics of Minnesota | Minneapolis, Minnesota, United States, 55404-4597 |
| New York University Medical Center | New York, New York, United States, 10016 |
| Seattle Children's Hospital | Seattle, Washington, United States, 98105 |