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Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer

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: NCT00004065
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

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 17-N-allylamino-17-demethoxygeldanamycin in treating patients with refractory advanced solid tumors or hematologic cancers.

Condition or disease Intervention/treatment Phase
Bladder Cancer Breast Cancer Colorectal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Lung Cancer Melanoma (Skin) Ovarian Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific Drug: tanespimycin Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with refractory or advanced solid tumors or hematologic malignancies.
  • Evaluate the effects of this drug on the expression of signaling proteins present on an individual patient's cancer at the start of treatment and, if possible, post treatment.

OUTLINE: This is a two-phase, dose-escalation, multicenter study. Patients are stratified according to disease (chronic myelogenous leukemia [CML] or Philadelphia chromosome [Ph]+ acute lymphoblastic leukemia [ALL] vs solid tumor).

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-90 minutes twice weekly. Courses repeat every 12 weeks in the absence of disease progression (after at least 2 courses for CML or Ph+ ALL patients) or unacceptable toxicity.

  • Accelerated phase: Single patients receive escalating dose levels of 17-AAG until one patient experiences a first course grade 3 or greater toxicity or two different patients experience grade 2 toxicity during any course.
  • Standard phase: Cohorts of 3-6 patients in each stratum receive escalating doses of 17-AAG 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.

PROJECTED ACCRUAL: Approximately 51 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Trial of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG, NSC #330507) Daily X 5 in Patients With Advanced Cancer Therapeutic Protocol
Study Start Date : July 1999
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Information from the National Library of Medicine

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


  • Diagnosis of 1 of the following:

    • Histologically confirmed advanced primary or malignant solid tumor refractory to standard therapy or for which no curative standard therapy exists

      • Progressive disease evidenced by 1 of the following:

        • Non-prostate cancer (including, but not limited to, breast, ovary, head and neck, non-small cell lung, bladder, kidney, colon, stomach, or malignant melanoma)

          • Development of new lesions or an increase in existing lesions
          • No increase in a biochemical marker (e.g., carcinoembryonic antigen, CA-15-3, or an increase in symptoms) as sole measure of disease
    • Prostate cancer (androgen independent) meeting the following criteria:

      • Progressing metastatic disease on bone scan, CT scan, or MRI
      • Metastatic disease and rising prostate-specific antigen (PSA) values meeting 1 of the following criteria:

        • At least 3 rising PSA values obtained at least 1 week apart = 2 rising values more than 1 month apart with at least 25% increase over the range of values
      • Serum testosterone less than 30 ng/mL
      • Castrate status should be maintained by medical therapies if orchiectomy has not been performed
      • Progressive disease must be evident off antiandrogen therapy if received prior to study entry
      • Registered to protocol MSKCC-9040
    • Cytologically confirmed chronic, accelerated, or blastic phase chronic myelogenous leukemia (CML) or Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL) refractory to standard therapy or for which no curative therapy exists

      • Progressive disease evidenced by 1 of the following:

        • Accelerated or blastic phase disease that is not responsive to standard therapy or loss of hematologic response to imatinib mesylate while remaining in chronic phase for CML
        • Relapsed or refractory after treatment with standard chemotherapy and imatinib mesylate for Ph-positive ALL
  • No active CNS or epidural tumor
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 6 months


  • WBC greater than 3,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • No restrictions based on peripheral blood counts for CML and Ph-positive ALL


  • Bilirubin no greater than 1.2 times upper limit of normal (ULN)
  • AST less than 1.5 times ULN
  • Prothrombin time normal


  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance greater than 60 mL/min


  • No myocardial infarction within the past 6 months
  • Ejection fraction greater than 45% by radionuclide cardiac angiography
  • No ventricular aneurysm or other abnormal wall motion
  • No reversible defect by thallium stress test if any of the following conditions are present:

    • Ejection fraction less than 45% on radionuclide angiocardiography
    • Worrisome but nonexclusive cardiovascular history
    • Abnormal echocardiogram
  • Patients with the following history or clinical findings require additional diagnostic testing:

    • Significant Q waves (greater than 3 mm or greater than one-third of the height of the QRS complex)
    • ST elevation or depressions of greater than 2 mm that are not attributable to hypertension strain
    • Absence of regular sinus rhythm
    • Bundle branch block
    • Requirement for diuretics for reasons other than hypertension or digoxin for reasons other than atrial fibrillation
    • Prior mild to moderate congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No angina pectoris
  • No uncontrolled hypertension or intermittent claudication
  • No severe debilitating valvular disease


  • No severe debilitating pulmonary disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring IV antibiotics
  • No symptomatic peripheral neuropathy grade 2 or higher
  • No other severe medical conditions that would increase risk for toxicity
  • No allergy to eggs or egg products


Biologic therapy:

  • At least 4 weeks since prior biologic therapy (including interferon for CML) and recovered


  • At least 4 weeks since prior chemotherapy (3 days for hydroxyurea for CML or ALL) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior endocrine therapy and recovered


  • At least 4 weeks since prior radiotherapy and recovered
  • Concurrent radiotherapy to localized disease sites not being used to evaluate antitumor response allowed
  • No concurrent radiotherapy to only measurable lesion


  • See Disease Characteristics
  • Prior orchiectomy allowed
  • No concurrent surgery


  • At least 3 days since prior imatinib mesylate for CML or ALL
  • At least 4 weeks since prior investigational anticancer drugs and recovered
  • At least 4 weeks since prior palliative treatment for metastatic disease
  • No concurrent ketoconazole, warfarin, verapamil, miconazole, or erythromycin
  • No other concurrent investigational drugs

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): NCT00004065

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Howard I. Scher, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00004065    
Other Study ID Numbers: 99-037
CDR0000067267 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
stage III colon cancer
stage IV colon cancer
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage III gastric cancer
stage IV gastric cancer
recurrent gastric cancer
stage IIIB breast cancer
stage IIIC breast cancer
recurrent non-small cell lung cancer
recurrent colon cancer
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
stage III bladder cancer
recurrent bladder cancer
stage IV bladder cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
stage III melanoma
stage IV melanoma
recurrent melanoma
stage IIIA non-small cell lung cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Stomach Neoplasms
Head and Neck Neoplasms
Urinary Bladder Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Stomach Diseases