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AzTrials

Male Breast CancerPhase 1NCT00089362

Alvespimycin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors

A Phase 1 study testing alvespimycin hydrochloride, laboratory biomarker analysis and pharmacological study in people with Male Breast Cancer and Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, run by National Cancer Institute (NCI) at 1 site 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

This phase I trial is studying the side effects and best dose of alvespimycin hydrochloride in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as alvespimycin hydrochloride, work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
alvespimycin hydrochloride, laboratory biomarker analysis and pharmacological study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Jul 2004to Jan 2008
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

Who may be able to join

  • Histologically confirmed solid tumor, including, but not limited to, the following:
  • Prostate
  • Breast
  • Ovary
  • Colon
  • Kidney
Show all 78Show fewer
  • Head and neck
  • Stomach
  • Melanoma
  • Metastatic or unresectable disease
  • No standard curative or palliative therapy exists or is no longer effective
  • Progressive disease as indicated by the following:
  • Non-prostate cancer
  • New lesions or increase in pre-existing lesions on bone scintigraphy, CT scan, MRI, or by physical examination
  • No increase in biochemical markers (e.g., carcinoembryonic antigen or CA-15-3) or symptoms as sole evidence of disease progression
  • Prostate cancer
  • Must have castrate metastatic disease (i.e., disease progression after castration or treatment with a gonadotropin-releasing hormone [GnRH] analog)
  • Patients who have not undergone surgical orchiectomy must continue with medical therapy (i.e., GnRH analogs) to maintain castrate levels of serum testosterone < 50 ng/dL
  • Patients who received an antiandrogen as part of first-line hormonal therapy must show disease progression after discontinuing treatment
  • Progressive metastatic disease on imaging studies (e.g., bone scan, CT scan, or MRI) OR metastatic disease and a rising prostate-specific antigen (PSA) allowed
  • Biochemical progression is defined as a minimum of 3 rising PSA values from baseline obtained at least 1 week apart OR 2 rising PSA values obtained more than 1 month apart, with >= 25% increase in value
  • No active brain metastases
  • Hormone receptor status:
  • Not specified
  • Male or female
  • Performance status - Karnofsky 70-100%
  • Performance status - ECOG 0-1
  • More than 6 months
  • WBC >= 3, 000/mm^3
  • Absolute neutrophil count >= 1, 500/mm^3
  • Platelet count >= 100,000/mm^3
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • AST and ALT < 1.5 times ULN
  • PT normal
  • Creatinine =< 1.4 mg/dL
  • Creatinine clearance > 55 mL/min
  • QTc < 450 msec for male patients (470 msec for female patients)
  • LVEF > 40% by MUGA
  • No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation >= 3 beats in a row)
  • No myocardial infarction within the past year
  • No active ischemic heart disease within the past year
  • No New York Heart Association class III or IV congestive heart failure
  • No congenital long QT syndrome
  • No left bundle branch block
  • No poorly controlled angina
  • No history of uncontrolled dysrhythmias or requiring antiarrhythmic drugs
  • Calcium blockers and beta blockers allowed
  • No other significant cardiac disease
  • Oxygen saturation > 88%
  • Dyspnea < grade 2 at rest on room air
  • No clinically significant pulmonary comorbidity (e.g., severe chronic obstructive pulmonary disease)
  • No requirement for supplemental oxygen
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active or ongoing infection
  • No symptomatic peripheral neuropathy >= grade 2
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • More than 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas)
  • At least 1 week since prior ketoconazole
  • More than 4 weeks since prior radiotherapy
  • Recovered from all prior therapy
  • More than 4 weeks since prior investigational anticancer therapeutic drugs
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent administration of any of the following herbal remedies:
  • Hydrastis canadensis (goldenseal)
  • Hypericum perforatum (St. John's wort)
  • Uncaria tomentosa (cat's claw)
  • Echinacea angustifolia roots
  • Trifolium pratense (wild cherry)
  • Matricaria chamomilla (chamomile)
  • Glycyrrhiza glabra (licorice)
  • Dillapiol
  • Hypericin
  • Naringenin
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase 1 Study of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG, NSC #707545) in Patients With Solid Tumors.

This phase I trial is studying the side effects and best dose of alvespimycin hydrochloride in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as alvespimycin hydrochloride, work in different ways to stop tumor cells from dividing so they stop growing or die.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the toxic effects and maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with metastatic or unresectable solid tumors.

SECONDARY OBJECTIVES:

II. Determine the effects of this drug on the expression of Hsp90 client proteins in normal and tumor tissue samples from these patients.

OUTLINE: This is a dose-escalation study.

Patients receive alvespimycin hydrochloride IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-2 patients receive accelerated escalating doses of alvespimycin hydrochloride until at least 1 of 2 patients experience dose-limiting toxicity (DLT). Cohorts are then expanded to 3-6 patients who receive escalating doses (in a standard manner) of alvespimycin hydrochloride 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 DLT. Once the MTD is determined, 10 additional patients are treated at that dose.

Being tested
alvespimycin hydrochloride, laboratory biomarker analysis, pharmacological study
Medical subject headings
Breast Neoplasms, Male, Breast Neoplasms, Colonic Neoplasms, Esthesioneuroblastoma, Olfactory, Stomach Neoplasms, Melanoma, Carcinoma, Ovarian Epithelial, Prostatic Neoplasms

What participants receive

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

  • alvespimycin hydrochlorideDrug

    Also called 17-DMAG HCL, KOS-1022

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00089362
Study groupRoleWhat they receive
Treatment (alvespimycin hydrochloride)ExperimentalPatients receive alvespimycin hydrochloride IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-2 patients receive accelerated escalating doses of alvespimycin hydrochloride until at least 1 of 2 patients experience DLT. Cohorts are then expanded to 3-6 patients who receive escalating doses (in a standard manner) of alvespimycin hydrochloride until MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. Once the MTD is determined, 10 additional patients are treated at that dose.
Receives: Drug: alvespimycin hydrochloride; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD, defined as the dose level where the observed DLT incidence in no more than one out of six patients treated at a particular dose level

    Measured: 28 days

Timeline

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

  1. First posted5 Aug 2004 (estimated)
  2. Study startJul 2004
  3. Primary completionJan 2008

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00089362
Sponsor's protocol ID
NCI-2012-01455
Other IDs
04-053, MSKCC-04053, NCI-6542, CDR0000378288, U01CA069856
Status last verified
Apr 2013
First submitted
4 Aug 2004
Last updated
10 Apr 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing alvespimycin hydrochloride, laboratory biomarker analysis and pharmacological study in people with Male Breast Cancer and Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, run by National Cancer Institute (NCI) at 1 site 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?

The sponsor lists 78 inclusion and 0 exclusion criteria. 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 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does the primary outcome measure?

MTD, defined as the dose level where the observed DLT incidence in no more than one out of six patients treated at a particular dose level (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00089362.

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 10 Apr 2013.

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