Clinical Trials Directory

Trials / Terminated

TerminatedNCT00439296

ABT-751 With Chemotherapy for Relapsed Pediatric ALL

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

Status
Terminated
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
9 (actual)
Sponsor
Therapeutic Advances in Childhood Leukemia Consortium · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGABT-751Treatment Course 1: Oral capsule to be given daily for 21 days at assigned dose. Treatment Course 2: ABT-751 will be taken once daily, by mouth, at the assigned dose on days 15-35. Treatment Course 3: ABT-751 will be taken once daily, by mouth, at the assigned dose on days 1-21 followed by 1 week of rest.
DRUGDexamethasoneIn Treatment Course 1 only: * 10 mg/m2/day divided BID. * Take dexamethasone by mouth days 1-14.
DRUGPEG-asparaginaseIn Treatment Course 1: * 2500 IU's/m2/day. * Intramuscular injection (IM) on days 4, 11 and 18. In Treatment Course 2: * 2500 IU's/m2/day. * Intramuscular injection (IM) on day 15.
DRUGDoxorubicinIn Treatment Course 1 only: • 60 mg/m2/day IV over 15 minutes on day 1.
DRUGCytarabine* Given Intrathecally on day 1 of course 1 at the dose defined by age below. * 30 mg for patients age 1-1.99 * 50 mg for patients age 2-2.99 * 70 mg for patients \>3 years of age * Omit IT Ara-C on Day 1 if patient received IT therapy prior to study enrollment as part of diagnostic lumbar puncture procedure. In Treatment Course 2: • 75 mg/m2/day IV on days 2 through 5 and days 9 through 12.
DRUGMethotrexateIn Treatment Course 1: • Given Intrathecally on day 15 at the dose defined by age below. * 8 mg for patients age 1-1.99 * 10 mg for patients age 2-2.99 * 12 mg for patients 3-8.99 years of age * 15 mg for patients \>9 years of age In Treatment Course 2: • Given Intrathecally on day 1, 8, 15 and 22 at the dose defined by age below. * 8 mg for patients age 1-1.99 * 10 mg for patients age 2-2.99 * 12 mg for patients 3-8.99 years of age * 15 mg for patients \>9 years of age In Treatment Course 3: Intrathecally on day 1 at the age-defined dose
DRUGCyclophosphamideCourse 2 only: • 1000mg/m2/day IV over 30 minutes to be given on day 1.
DRUG6-thioguanineTreatment Course 2 only: • 60 mg/m2/day to be given orally on days 1 through 14.

Timeline

Start date
2006-05-22
Primary completion
2009-05-19
Completion
2009-09-23
First posted
2007-02-23
Last updated
2021-03-17
Results posted
2020-09-09

Locations

5 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT00439296. Inclusion in this directory is not an endorsement.