17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
A Phase I Study of 17-AAG in Relapsed/Refractory Pediatric Patients With Solid Tumors or Leukemia
5 other identifiers
interventional
36
1 country
1
Brief Summary
This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating young patients with relapsed or refractory solid tumors or leukemia. Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop cancer cells from dividing so they stop growing or die.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 8, 2004
CompletedFirst Posted
Study publicly available on registry
March 10, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedJune 5, 2013
June 1, 2013
2.2 years
March 8, 2004
June 3, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
MTD defined as the maximum dose at which fewer than one-third of patients experience DLT
21 days
Study Arms (1)
Arm I
EXPERIMENTALPatients with solid tumors receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-120 minutes on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of solid tumor or leukemia with documented M3 marrow
- Histologic confirmation of intrinsic brain stem tumors not required
- Relapsed or refractory disease
- No known curative therapy
- In patients with CNS tumors, neurologic deficits must be stable for at least the past week
- Performance status - Karnofsky 50-100% (\>10 years of age)
- Performance status - Lansky 50-100% (≤ 10 years of age)
- For patients with solid tumors:
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3 (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
- For patients with leukemia:
- Platelet count ≥ 20,000/mm\^3 (may receive platelet transfusions)
- Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- +33 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
COG Phase I Consortium
Arcadia, California, 91006-3776, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brenda Weigel
COG Phase I Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2004
First Posted
March 10, 2004
Study Start
March 1, 2004
Primary Completion
May 1, 2006
Last Updated
June 5, 2013
Record last verified: 2013-06