DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



ABT-751 With Chemotherapy for Relapsed Pediatric ALL

Information source: Therapeutic Advances in Childhood Leukemia Consortium
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrent Pediatric ALL; Relapsed Pediatric ALL; Acute Lymphoblastic Leukemia; Refractory Pediatric ALL

Intervention: ABT-751 (Drug); dexamethasone (Drug); PEG-asparaginase (Drug); doxorubicin (Drug); cytarabine (Drug); methotrexate (Drug); cyclophosphamide (Drug); 6-thioguanine (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Therapeutic Advances in Childhood Leukemia Consortium

Official(s) and/or principal investigator(s):
Paul S Gaynon, MD, Study Chair, Affiliation: Childrens Hospital Los Angeles, Therapeutic Advances in Childhood Leukemia Consortium

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.

Clinical Details

Official title: A Phase I/II Trial of ABT-751 Combined With Dexamethasone, PEG-asparaginase, and Doxorubicin in Relapsed Acute Lymphoblastic Leukemia (ALL)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Dose Limiting Toxicity

Maximum Tolerated Dose

Secondary outcome:

Rate of Remission

Pharmacokinetic profile on blood and CSF

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.

Eligibility

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.

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.

Locations and Contacts

City of Hope, Duarte, California 91010, United States

Childrens Hospital Los Angeles, Los Angeles, California 90027, United States

Stanford University Medical Center, Palo Alto, California 94304-1812, United States

UCSF School of Medicine, San Francisco, California 94143-0106, United States

University of Miami Cancer Center, Miami, Florida 33136, United States

C.S. Mott Children's Hospital, Ann Arbor, Michigan 48109-0914, United States

Childrens Hospital & Clinics of Minnesota, Minneapolis, Minnesota 55404-4597, United States

New York University Medical Center, New York, New York 10016, United States

Seattle Children's Hospital, Seattle, Washington 98105, United States

Additional Information

Click here for more information about this protocol and the Therapeutic Advances in Childhood Leukemia Consortium

Starting date: May 2006
Last updated: November 28, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017