NCT00089362

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Last Updated

April 10, 2013

Status Verified

April 1, 2013

Enrollment Period

3.5 years

First QC Date

August 4, 2004

Last Update Submit

April 9, 2013

Conditions

Male Breast CancerRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Basal Cell Carcinoma of the LipRecurrent Breast CancerRecurrent Colon CancerRecurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityRecurrent Gastric CancerRecurrent Inverted Papilloma of the Paranasal Sinus and Nasal CavityRecurrent Lymphoepithelioma of the NasopharynxRecurrent Lymphoepithelioma of the OropharynxRecurrent MelanomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Ovarian Epithelial CancerRecurrent Prostate CancerRecurrent Renal Cell CancerRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavityStage III Adenoid Cystic Carcinoma of the Oral CavityStage III Basal Cell Carcinoma of the LipStage III Colon CancerStage III Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage III Gastric CancerStage III Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage III Lymphoepithelioma of the NasopharynxStage III Lymphoepithelioma of the OropharynxStage III MelanomaStage III Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage III Mucoepidermoid Carcinoma of the Oral CavityStage III Ovarian Epithelial CancerStage III Renal Cell CancerStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage III Verrucous Carcinoma of the LarynxStage III Verrucous Carcinoma of the Oral CavityStage IIIB Breast CancerStage IIIC Breast CancerStage IV Adenoid Cystic Carcinoma of the Oral CavityStage IV Basal Cell Carcinoma of the LipStage IV Breast CancerStage IV Colon CancerStage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage IV Gastric CancerStage IV Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage IV Lymphoepithelioma of the NasopharynxStage IV Lymphoepithelioma of the OropharynxStage IV MelanomaStage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage IV Mucoepidermoid Carcinoma of the Oral CavityStage IV Ovarian Epithelial CancerStage IV Prostate CancerStage IV Renal Cell CancerStage IV Salivary Gland CancerStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IV Verrucous Carcinoma of the LarynxStage IV Verrucous Carcinoma of the Oral CavityUnspecified Adult Solid Tumor, Protocol SpecificUntreated Metastatic Squamous Neck Cancer With Occult Primary

Outcome Measures

Primary Outcomes (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

    28 days

Study Arms (1)

Treatment (alvespimycin hydrochloride)

EXPERIMENTAL

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 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.

Drug: alvespimycin hydrochlorideOther: laboratory biomarker analysisOther: pharmacological study

Interventions

alvespimycin hydrochlorideDRUG

Given IV

Also known as: 17-DMAG HCL, KOS-1022
Treatment (alvespimycin hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (alvespimycin hydrochloride)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (alvespimycin hydrochloride)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed solid tumor, including, but not limited to, the following:
  • Prostate
  • Breast
  • Ovary
  • Colon
  • Kidney
  • 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
  • +63 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, MaleBreast NeoplasmsColonic NeoplasmsEsthesioneuroblastoma, OlfactoryStomach NeoplasmsMelanomaCarcinoma, Ovarian EpithelialProstatic NeoplasmsCarcinoma, Renal CellSalivary Gland NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

17-(dimethylaminoethylamino)-17-demethoxygeldanamycin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesStomach DiseasesNeuroendocrine TumorsNevi and MelanomasSkin NeoplasmsCarcinomaOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesAdenocarcinomaKidney NeoplasmsUrologic NeoplasmsKidney DiseasesUrologic DiseasesMouth NeoplasmsHead and Neck NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesCarcinoma, Squamous Cell

Study Officials

  • David Solit

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

July 1, 2004

Primary Completion

January 1, 2008

Last Updated

April 10, 2013

Record last verified: 2013-04

Locations

US(1)