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AzTrials

Bladder CancerPhase 1NCT00004065

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

A Phase 1 study testing tanespimycin in people with Bladder Cancer and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer, Breast Cancer, Colorectal Cancer
What is being tested?
tanespimycin
How many people
Not given
Where
2 sitesUnited States
Study dates
Jul 1999to Mar 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
tanespimycin
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, relapsing chronic myelogenous leukemia
Medical subject headings
Urinary Bladder Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Head and Neck Neoplasms, Kidney Neoplasms, Leukemia, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tanespimycinDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 1999
  3. Primary completionMar 2005
  4. Study completionMar 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004065
Sponsor's protocol ID
99-037
Other IDs
CDR0000067267, NCI-T99-0035, UCLA-0206019
Status last verified
Jun 2013
First submitted
10 Dec 1999
Last updated
24 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tanespimycin in people with Bladder Cancer and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.

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Clinical Trial NCT00004065 | AzTrials