17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
Completed · Phase 1
Conditions studied: Acute Undifferentiated Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Unspecified Childhood Solid Tumor, Protocol Specific
In brief
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.
Key facts
- Study ID
- NCT00079404
- Run by
- National Cancer Institute (NCI)
- People needed
- 36
- Starts
- 2004-03-01
- Last updated by the study team
- 2013-06-05
Who can join
Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
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)
- ALT ≤ 2.5 times ULN
- Albumin ≥ 2 g/dL
- Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min
- Creatinine based on age as follows:
- ≤ 0.8 mg/dL if ≤ 5 years of age
- ≤ 1.0 mg/dL if > 5 years and ≤ 10 years of age
- ≤ 1.2 mg/dL if > 10 years and ≤ 15 years of age
- ≤ 1.5 mg/dL if > 15 years and ≤ 21 years of age
- No uncontrolled infection
- No prior severe allergy to eggs
Where it is running
- COG Phase I Consortium — Arcadia, California, United States
Full record on ClinicalTrials.gov
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