Clinical trial · Interventional
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
NCT00079404CI-TRIAL-00010612completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Undifferentiated Leukemia | Acute Undifferentiated Leukemia | ONTOLOGY_EXACT | 0.90 |
| Recurrent Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Childhood Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Secondary Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tanespimycin | Drug | Tanespimycin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients 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.
- interventionNames
- Drug: tanespimycin
Primary outcomes (1)
- measure
- MTD defined as the maximum dose at which fewer than one-third of patients experience DLT
- timeFrame
- 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * No situation that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * At least 7 days (or window for adverse effects has passed) since prior biologic therapy and recovered * At least 7 days since prior hematopoietic growth factors * At least 2 months since prior stem cell transplantation and no evidence of graft-vs-host disease * No concurrent hematopoietic growth factors * No concurrent biologic therapy * No concurrent immunotherapy * At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered * No other concurrent chemotherapy * No concurrent steroid therapy * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 3 months since prior total body irradiation or craniospinal radiotherapy * At least 3 months since prior radiotherapy to ≥ 50% of the pelvis * At least 6 weeks since prior substantial bone marrow radiotherapy * Recovered from prior radiotherapy * No concurrent radiotherapy * No other concurrent investigational drugs * No other concurrent anticancer agents * No concurrent phenytoin or phenobarbital * No concurrent warfarin
References
Publications (0)
Data not yet available
No reference posted for this study.