Expired Study
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Detroit, Michigan 48201


Purpose:

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as 17-N-allylamino-17-demethoxygeldanamycin use different ways to stop cancer cells from dividing so they stop growing or die. Combining imatinib mesylate with chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin when given together with imatinib mesylate in treating patients with chronic myelogenous leukemia.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when administered with imatinib mesylate in patients with chronic myelogenous leukemia. - Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). Patients receive oral imatinib mesylate on days 1-21 and 17-AAG IV over 1 hour on days 1, 4, 8, and 12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 6-10 patients receives treatment at the recommended phase II dose. PROJECTED ACCRUAL: Approximately 21-42 patients will be accrued for this study within 1.5 years.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of chronic myelogenous leukemia, including any of the following phases: - Blastic phase - Greater than 30% blasts in the peripheral blood or bone marrow - Previously untreated disease OR refractory to or relapsed after most recent therapy - Accelerated phase, defined by 1 of the following: - At least 15, but less than 30%, blasts in the peripheral blood or bone marrow - At least 30% blasts and promyelocytes in the peripheral blood or bone marrow - Greater than 20% peripheral blood basophilia - Chronic phase - No major cytogenetic response (less than 65% Philadelphia chromosome negative) after 12 months of prior imatinib mesylate therapy - Philadelphia chromosome positive by routine cytogenetics PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Not specified Hepatic - Bilirubin no greater than 1.5 mg/dL - ALT and AST no greater than 2.5 times upper limit of normal Renal - Creatinine less than 1.5 mg/dL Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known allergy to eggs - Able to swallow pills - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No other concurrent uncontrolled medical illness PRIOR CONCURRENT THERAPY: Biologic therapy - No prior stem cell transplantation Chemotherapy - More than 4 weeks since prior chemotherapy (except hydroxyurea or anagrelide) (at least 6 weeks for nitrosoureas or mitomycin) Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - No prior liver, kidney, or lung transplantation - More than 14 days since prior major surgery (e.g., thoracotomy or intra-abdominal surgery) Other - Prior imatinib mesylate administered within the past 4 weeks is allowed - No concurrent tacrolimus or cyclosporine as immunosuppressive agents - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent agents that alter CYP3A4 activity, including any of the following: - Grapefruit juice - Ketoconazole - Fluconazole - Itraconazole - Erythromycin - Clarithromycin - Cimetidine - Terfenadine - Astemizole - HIV protease inhibitors (e.g., indinavir and nelfinavir)


Study is Available At:


Original ID:

CDR0000315521


NCT ID:

NCT00066326


Secondary ID:

U01CA062487


Study Acronym:


Brief Title:

Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia


Official Title:

Phase I Study Of The Combination Of 17-AAG And Imatinib Mesylate (Gleevec) In Patients With Blastic Phase, Accelerated Phase Of Chronic Mesylate Leukemia (CML) Or Patients With Chronic Phase CML Who Have Not Achieved A Cytogenetic Response With Imatinib M


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Barbara Ann Karmanos Cancer Institute


Oversight Authority:

  • United States: Federal Government
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Charles A. Schiffer, MD
Study Chair
Barbara Ann Karmanos Cancer Institute

Study Dates

Start Date:June 2003
Completion Date:September 2005
Completion Type:Actual
Primary Completion Date:October 2004
Primary Completion Type:Actual
Verification Date:April 2013
Last Changed Date:April 3, 2013
First Received Date:August 6, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:imatinib mesylate
Intervention Type:Drug
Name:tanespimycin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Barbara Ann Karmanos Cancer Institute
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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