Working… Menu

17-Dimethylaminoethylamino-17-Demethoxygeldanamycin (17-DMAG) in Treating Patients With Metastatic Solid Tumors or Tumors That Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00248521
Recruitment Status : Unknown
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : November 4, 2005
Last Update Posted : August 2, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic solid tumors or tumors that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: alvespimycin hydrochloride Phase 1

Detailed Description:



  • Determine the maximum tolerated dose, dose-limiting toxicity, and recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with unresectable or metastatic solid tumors.
  • Determine the feasibility, safety, and toxicity profile of this drug in these patients.


  • Determine the clinical pharmacokinetic profile of this drug in these patients.
  • Determine tumor response in patients treated with this drug.
  • Determine the biologically effective dose.

OUTLINE: This is an open-label, non-randomized, dose-escalation, multicenter study.

Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1 hour on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of 17-DMAG 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. An additional 10 patients are treated at the MTD.

After completion of study treatment, patients are followed for 28 days.

PROJECTED ACCRUAL: Approximately 25-35 patients will be accrued for this study within 12-18 months.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cancer Research UK Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of 17-Dimethylaminoethyl-amino-17-Demethoxygeldanamycin (17-DMAG) Given as a Once Weekly Infusion in Patients With Advanced Solid Tumors
Study Start Date : October 2005
Estimated Primary Completion Date : January 2007

Primary Outcome Measures :
  1. Recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) at 28 days after treatment

Secondary Outcome Measures :
  1. Heat shock protein 90 (HSP90) client protein and co-chaperone changes up to 29 days after treatment
  2. Tumor response by RECIST criteria every 6 weeks while on study
  3. Clinical pharmacokinetic profile established during the first course of treatment

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed solid tumor

    • Unresectable or metastatic disease
  • Standard curative or palliative measures do not exist OR are no longer effective OR patient refused such measures
  • No known brain metastases



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 12 weeks


  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL


  • Bilirubin normal
  • ALT and AST ≤ 1.5 times upper limit of normal
  • No chronic liver disease
  • Hepatitis B or C negative


  • Creatinine normal OR
  • Creatinine clearance normal


  • No symptomatic New York Heart Association class III-IV cardiac disease
  • No myocardial infarction within the past year
  • No active ischemic heart disease within the past year
  • No poorly controlled angina
  • No uncontrolled dysrhythmia or dysrhythmias requiring antiarrhythmic drugs
  • No transient ischemic attack
  • No stroke
  • No peripheral vascular disease
  • No congenital long QT syndrome
  • No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • QTc < 450 msec (for men) and 470 msec (for woman)
  • LVEF > 40% by MUGA
  • No left bundle branch block


  • No symptomatic pulmonary disease requiring medication, including any of the following:

    • Dyspnea with or without exertion
    • Paroxysmal nocturnal dyspnea
    • Oxygen requirement
    • Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception 4 weeks before, during, and for 6 months after completion of study treatment
  • No known HIV positivity
  • No other malignancy within the past 5 years except adequately treated cone biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  • No ongoing or active infection
  • No diabetes mellitus (with evidence of severe peripheral vascular disease or ulcers)
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness


Biologic therapy

  • More than 4 weeks since prior immunotherapy
  • Concurrent epoetin alfa allowed


  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No prior 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)

Endocrine therapy

  • More than 4 weeks since prior endocrine therapy
  • Concurrent luteinizing hormone-releasing hormone analogues for androgen-insensitive prostate cancer and rising prostate-specific antigen allowed


  • More than 4 weeks since prior radiotherapy (except for palliative treatment)
  • No prior irradiation field that potentially included the heart (e.g., mantle)


  • Not specified


  • Recovered from all prior therapy
  • Concurrent bisphosphonates allowed
  • At least 5 half-lives since prior and no concurrent medication that prolong QTc
  • No other concurrent anticancer or investigational agents
  • No concurrent grapefruit juice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00248521

Layout table for location information
United Kingdom
Institute of Cancer Research - Sutton
Sutton, England, United Kingdom, SM2 5NG
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
Belfast, Northern Ireland, United Kingdom, BT8 8JR
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Ian R. Judson, MA, MD, FRCP Institute of Cancer Research, United Kingdom
Publications of Results:
Pacey SC, Wilson RH, Walton M, et al.: A phase I trial of the heat shock protein 90 (HSP90) inhibitor alvespimycin (17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG) administered weekly, intravenously, to patients with advanced solid tumors. [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-PR-6, 2007.

Layout table for additonal information Identifier: NCT00248521    
Other Study ID Numbers: ICR-PH1/102
CDR0000442402 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: November 4, 2005    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: March 2008
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
Layout table for MeSH terms