Chemotherapy in Treating Patients With Refractory Advance... | NCT00004065 | Trialant
NCT00004065
Sponsor
Memorial Sloan Kettering Cancer Center
Status
Completed
Last Update Posted
Jun 24, 2013Estimated
Enrollment
Not provided
Phase
Phase 1
Conditions
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
Interventions
tanespimycin
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00004065
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
99-037
Secondary IDs
ID
Type
Description
Link
CDR0000067267
Registry Identifier
PDQ (Physician Data Query)
NCI-T99-0035
UCLA-0206019
Brief Title
Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer
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
Acronym
Not provided
Organization
Memorial Sloan Kettering Cancer CenterOTHER
Status Module
Record Verification Date
Jun 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 1999
Primary Completion Date
Mar 2005Actual
Completion Date
Mar 2005Actual
First Submitted Date
Dec 10, 1999
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 20, 2013
Last Update Posted Date
Jun 24, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Memorial Sloan Kettering Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Detailed Description
OBJECTIVES:
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.
Conditions Module
Conditions
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
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
tanespimycin
Drug
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age:
18 and over
Sex:
Not specified
Menopausal status:
Not specified
Performance status:
Karnofsky 70-100%
Life expectancy:
At least 6 months
Hematopoietic:
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
Hepatic:
Bilirubin no greater than 1.2 times upper limit of normal (ULN)
AST less than 1.5 times ULN
Prothrombin time normal
Renal:
Creatinine no greater than 1.5 times ULN OR
Creatinine clearance greater than 60 mL/min
Cardiovascular:
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
Pulmonary:
No severe debilitating pulmonary disease
Other:
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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 4 weeks since prior biologic therapy (including interferon for CML) and recovered
Chemotherapy:
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
Radiotherapy:
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
Surgery:
See Disease Characteristics
Prior orchiectomy allowed
No concurrent surgery
Other:
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Howard I. Scher, MD
Memorial Sloan Kettering Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles
California
90095
United States
Memorial Sloan-Kettering Cancer Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
unspecified adult solid tumor, protocol specific
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
untreated metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary
ovarian stromal cancer
stage III ovarian germ cell tumor
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor
stage III squamous cell carcinoma of the lip and oral cavity
stage III basal cell carcinoma of the lip
stage III mucoepidermoid carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV basal cell carcinoma of the lip
stage IV verrucous carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent basal cell carcinoma of the lip
recurrent verrucous carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent adenoid cystic carcinoma of the oral cavity
stage III squamous cell carcinoma of the oropharynx
stage III lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity
stage III midline lethal granuloma of the paranasal sinus and nasal cavity
stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity