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Status:

COMPLETED

17-AAG and Irinotecan in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

This phase I trial is studying the side effects and best dose of 17-AAG and irinotecan in treating patients with locally advanced or metastatic solid tumors. Drugs used in chemotherapy, such as 17-AAG...

Detailed Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of combined 17AAG and irinotecan given weekly for two weeks in a 21-day cycle that can be used for future phase II studies. SECON...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed solid tumor, excluding primary CNS tumors
  • Locally advanced or metastatic disease that is refractory to standard therapy OR for which no standard therapy exists
  • Tumor assessible for biopsy by Tru-cut\^®, CT guidance, or endoscopy (for patients treated at the maximum tolerated dose \[expanded cohort only\])
  • Pleural effusions or abdominal ascites are not considered biopsy-accessible tissue
  • No known new CNS metastases that have not been previously treated
  • Performance status - Karnofsky 60-100%
  • WBC ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin ≤ 1.5 mg/dL
  • AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • Creatinine ≤ 1.5 mg/dL
  • No history of cardiac arrhythmias
  • No myocardial infarction within the past 12 months
  • No active ischemic heart disease within the past 12 months
  • No New York Heart Association class III-IV congestive heart failure or LVEF \< 40% by MUGA
  • No history of uncontrolled cardiac dysrhythmia or dysrhthmias requiring medication
  • No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • No congenital long QT syndrome
  • No left bundle branch block
  • QTc \< 450 msec (for male patients)
  • QTc \< 470 msec (for female patients)
  • Not pregnant
  • No nursing during and for 2 months after study participation
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study participation
  • No serious or uncontrolled infection
  • No history of serious allergic reaction to eggs or egg products
  • No other medical condition that would preclude study participation
  • At least 3 weeks since prior immunotherapy
  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • Prior irinotecan allowed
  • No prior 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)
  • At least 2 weeks since prior non-myelosuppressive chemotherapy (at the discretion of the principal investigator)
  • At least 3 weeks since prior radiotherapy
  • No prior radiotherapy field that included the heart (e.g., mantle)
  • Recovered from all prior therapy
  • At least 3 weeks since prior anticancer investigational therapeutic drugs
  • More than 7 days since prior and no concurrent inducers, inhibitors, or modifiers of CYP3A4, including any of the following:
  • Fluconazole
  • Itraconazole
  • Ketoconazole
  • Azithromycin
  • Clarithromycin
  • Erythromycin
  • Troleandomycin
  • Nifedipine
  • Verapamil
  • Diltiazem
  • Nefazodone
  • Cyclosporine
  • Grapefruit juice (\> 1 quart/day)
  • Indinavir
  • Nelfinavir
  • Ritonavir
  • Saquinavir
  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • Rifampin
  • Hydrastis canadensis (goldenseal)
  • Hypericum perforatum (St. John's wort)
  • Uncaria tomentosa (cat's claw)
  • Echinacea angustifolia root
  • Trifolium pratense (wild cherry)
  • Matricaria chamomila (chamomile)
  • Glycyrrhiza glabra (licorice)
  • Dillapiol
  • Hypericin
  • Naringenin
  • No concurrent medications that would prolong QTc
  • No concurrent vitamins, antioxidants, herbal preparations, or supplements
  • Concurrent single daily multivitamin allowed
  • No other concurrent anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational medications

Exclusion

    Key Trial Info

    Start Date :

    May 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    48 Patients enrolled

    Trial Details

    Trial ID

    NCT00119236

    Start Date

    May 1 2005

    Last Update

    June 4 2013

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    Memorial Sloan Kettering Cancer Center

    New York, New York, United States, 10065