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A Phase I Pharmacokinetic and Pharmacodynamic Study of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) (NSC 330507) Via Intravenous Administration in Patients With Advanced Malignancies (NCT00003969)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of a geldanamycin analogue in treating patients with advanced cancer.
  • Drug: tanespimycin
    Ages eligible for Study
    18 Years to 75 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES:

    - Determine the maximum tolerated dose for a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), in patients with advanced malignancies.

    - Determine the toxic effects and dose-limiting toxicity of AAG in this patient population.

    - Determine the safe dose of AAG for a Phase II study.

    - Measure the pharmacokinetic and pharmacodynamic profiles of AAG in these patients.

    - Assess time to tumor progression and any antitumor activity in patients treated with AAG.

    OUTLINE: This is a dose-escalation study.

    Patients receive a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), IV over 15-30 minutes every week. Treatment continues in the absence of disease progression or unacceptable toxicity.

    Cohorts of 3-6 patients receive escalating doses of AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

    Patients are followed at 4 weeks.

    PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

    1 locations

    United Kingdom (1)
    • Royal Marsden NHS Foundation Trust - London
      London, England, United Kingdom, SW3 6JJ
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 July, 1998
    Updated:
    24 June, 2013
    Participants:
    0
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