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Geldanamycin Analogue in Treating Patients With Advanced Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: June 25, 2013
Last verified: December 2000

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.

Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: tanespimycin Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Pharmacokinetic and Pharmacodynamic Study of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) (NSC 330507) Via Intravenous Administration in Patients With Advanced Malignancies

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Recommended phase II dose of 17-allylamino-17-demethoxygeldanamycin (17-AAG) at 4 weeks

Secondary Outcome Measures:
  • Heat shock protein 90 (HSP90) client protein and co-chaperone changes during first course of treatment
  • Pharmacokinetic profile of 17-AAG during the first course of treatment

Study Start Date: August 1998
Study Completion Date: January 2007
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically proven malignancies refractory to conventional treatment or for which no standard therapy exists
  • Primary brain tumor or brain metastases allowed if stable symptoms within 2 weeks prior to study and able to give informed consent



  • 18 to 75

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months


  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL
  • Absolute neutrophil count at least 1,500/mm^3


  • Bilirubin less than 1.0 mg/dL
  • AST and ALT no greater than 2.5 times upper limit of normal if due to liver metastases
  • No chronic liver disease


  • Creatinine less than 1.47 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • No myocardial infarction within the past 6 months
  • No angina requiring treatment within the past 6 months
  • No uncompensated coronary artery disease by electrocardiogram or physical examination
  • No prior transient ischemic attacks, stroke, or peripheral vascular disease
  • LVEF at least 45%


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks after study
  • No allergy to egg products
  • No nonmalignant systemic disease that would increase risk
  • No active uncontrolled infection
  • No diabetes mellitus with evidence of severe peripheral vascular disease or diabetic ulcers


Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since other prior endocrine therapy and recovered
  • Concurrent corticosteroids for symptom control allowed if no change in dose requirement within 2 weeks prior to study


  • At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered
  • Concurrent radiotherapy allowed for control of bone pain or as indicated


  • Not specified


  • No other concurrent investigational treatment
  • No concurrent treatment with drugs interfering with hepatic CYP3A4 metabolism (e.g., grapefruit juice or warfarin)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003969

United Kingdom
Royal Marsden NHS Foundation Trust - London
London, England, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Cancer Research UK
Study Chair: Ian R. Judson, MA, MD, FRCP Royal Marsden NHS Foundation Trust
  More Information

Publications: Identifier: NCT00003969     History of Changes
Other Study ID Numbers: CRC-PHASE-I-PH1/074
CDR0000067170 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: November 1, 1999
Last Updated: June 25, 2013

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific processed this record on September 25, 2017