Clinical trial · Interventional
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Imatinib Mesylate
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered CNF1010 )17-(Allylamino)-17-Demethoxygeldanamycin [17-AAG]) in Patients With Gleevec-Resistent Chronic Myelogenous Leukemia
NCT00100997CI-TRIAL-00011274completedPhase 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)
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with chronic phase chronic myelogenous leukemia that did not respond to imatinib mesylate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tanespimycin | Drug | Tanespimycin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of chronic phase chronic myelogenous leukemia * Philadelphia chromosome (Ph)-positive disease * Hematologic resistence after treatment with imatinib mesylate (400 mg per day or maximum tolerated dose \[MTD\]) as defined by 1 of the following criteria: * Loss of complete hematologic response, defined as WBC count OR platelet count \> upper limit of normal (ULN) on 2 separate occasions at least 2 weeks apart that cannot be attributed to other etiologies * Absolute increase of ≥ 30% in Ph-positive cells while on a stable dose of imatinib mesylate for at least 6 months\* NOTE: \*Patients meeting this criterion are not eligible for enrollment into the expanded MTD cohort * Less than 15% blasts in peripheral blood or bone marrow AND \< 30% blasts and promyelocytes in peripheral blood or bone marrow PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * See Disease Characteristics Hepatic * Bilirubin \< 1.5 times ULN (3 mg/dL for patients with Gilbert's syndrome) * ALT or AST \< 2 times ULN * No known hepatitis positivity Renal * Creatinine \< 1.5 times ULN OR * Creatinine clearance \> 60 mL/min Cardiovascular * No New York Heart Association class III or IV cardiac disease Pulmonary * No severe debilitating pulmonary disease, including any of the following: * Dyspnea at rest * Significant shortness of breath * Chronic obstructive pulmonary disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 month after study participation * No known HIV positivity * No psychological or social condition that would preclude study compliance * No addictive disorder that would preclude study compliance * No family problems that would preclude study compliance * No known allergy or sensitivity to soy or other excipient components of study drug * No other illness or condition that may affect safety of study treatment or evaluation of study endpoints PRIOR CONCURRENT THERAPY: Biologic therapy * More than 2 weeks since prior interferon * No concurrent interferon Chemotherapy * More than 2 weeks since prior cytarabine (4 weeks for doses \> 100 mg) * More than 6 weeks since prior busulfan * No concurrent cytarabine * No concurrent hydroxyurea during the second study treatment course and beyond * No concurrent anagrelide during the second study treatment course and beyond Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 2 days since prior imatinib mesylate * More than 1 week since prior and no concurrent drugs that alter metabolism by cytochrome P450 3A4, including the following: * Diltiazem * Nifedipine * Verapamil * Fluconazole * Itraconazole * Ketoconazole * Lovastatin * Simvastatin * Indinavir * Nelfinavir * Ritonavir * Alprazolam * Diazepam * Midazolam * Triazolam * Phenobarbital * Phenytoin * Carbamazepine * Azithromycin * Clarithromycin * Erythromycin * Rifampin * Rifamycin * Astemizole * Terfenidine * Amiodarone * Cimetidine * Cisapride * Cyclosporine * Grapefruit juice * Hypericum perforatum (St. John's wort) * Warfarin * More than 4 weeks since prior investigational drugs and recovered * No concurrent imatinib mesylate
References
Publications (0)
Data not yet available
No reference posted for this study.