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Status:

UNKNOWN

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

Lead Sponsor:

Institute of Cancer Research, United Kingdom

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 b...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose, dose-limiting toxicity, and recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with un...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • More than 12 weeks
  • Hematopoietic
  • Absolute neutrophil count \> 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9.0 g/dL
  • Hepatic
  • Bilirubin normal
  • ALT and AST ≤ 1.5 times upper limit of normal
  • No chronic liver disease
  • Hepatitis B or C negative
  • Renal
  • Creatinine normal OR
  • Creatinine clearance normal
  • Cardiovascular
  • 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
  • Pulmonary
  • 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
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 4 weeks since prior immunotherapy
  • Concurrent epoetin alfa allowed
  • Chemotherapy
  • 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
  • Radiotherapy
  • More than 4 weeks since prior radiotherapy (except for palliative treatment)
  • No prior irradiation field that potentially included the heart (e.g., mantle)
  • Surgery
  • Not specified
  • Other
  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    35 Patients enrolled

    Trial Details

    Trial ID

    NCT00248521

    Start Date

    October 1 2005

    Last Update

    August 2 2013

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Institute of Cancer Research - Sutton

    Sutton, England, United Kingdom, SM2 5NG

    2

    Royal Marsden - Surrey

    Sutton, England, United Kingdom, SM2 5PT

    3

    Belfast City Hospital Trust Incorporating Belvoir Park Hospital

    Belfast, Northern Ireland, United Kingdom, BT8 8JR