17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Imatinib Mesylate

NCT00100997 | Completed Phase 1

• 4 other identifiers: UCLA-0408048-01CDR0000407499CTC-CNF1010CTC-CNF1010-CML-04001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Leukemia

Keywords

chronic myelogenous leukemia, BCR-ABL1 positive; chronic phase chronic myelogenous leukemia; relapsing chronic myelogenous leukemia

Interventions

tanespimycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Sawyers, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2005
• First Posted: January 10, 2005
• Study Start: October 1, 2004
• Study Completion: October 1, 2006
• Last Updated: July 10, 2013

Record last verified: 2005-05

Locations

US (1)