Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

laboratory biomarker analysis

+ pharmacological study

+ alvespimycin hydrochloride

OtherDrug
Who is being recruted

Squamous Cell Carcinoma of Head and Neck+100

+ Carcinoma, Ovarian Epithelial

+ Nasopharyngeal Carcinoma

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2004

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. 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.

Official TitlePhase 1 Study of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG, NSC #707545) in Patients With Solid Tumors. 
NCT00089362
Principal SponsorNational Cancer Institute (NCI)
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Squamous Cell Carcinoma of Head and NeckCarcinoma, Ovarian EpithelialNasopharyngeal CarcinomaUrogenital DiseasesGenital DiseasesAdenocarcinomaAdnexal DiseasesBreast DiseasesBreast NeoplasmsCarcinomaCarcinoma, Basal CellCarcinoma, Renal CellCarcinoma, Squamous CellColonic DiseasesColonic NeoplasmsCranial Nerve DiseasesCarcinoma, Adenoid CysticDigestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, FemaleGenital Diseases, MaleGenital Neoplasms, FemaleGenital Neoplasms, MaleGonadal DisordersGranulomaHead and Neck NeoplasmsIntestinal DiseasesIntestinal NeoplasmsKidney DiseasesKidney NeoplasmsLaryngeal DiseasesLaryngeal NeoplasmsLymphatic DiseasesLymphoproliferative DisordersMelanomaStomatognathic DiseasesMouth DiseasesMouth NeoplasmsNasopharyngeal DiseasesNasopharyngeal NeoplasmsNeoplasm MetastasisNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplasms, Unknown PrimaryNeoplastic ProcessesNervous System DiseasesNeuroblastomaNose DiseasesNose NeoplasmsOropharyngeal NeoplasmsOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsOvarian DiseasesOvarian NeoplasmsPapillomaParanasal Sinus DiseasesParanasal Sinus NeoplasmsPathologic ProcessesPharyngeal DiseasesPharyngeal NeoplasmsProstatic DiseasesProstatic NeoplasmsRecurrenceRespiratory Tract DiseasesRespiratory Tract NeoplasmsSalivary Gland DiseasesSalivary Gland NeoplasmsSkin DiseasesSkin NeoplasmsStomach DiseasesStomach NeoplasmsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsColorectal NeoplasmsNeuroectodermal TumorsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveCarcinoma, MucoepidermoidCarcinoma, VerrucousNeoplasms, Basal CellNeoplasms, Cystic, Mucinous, and SerousMucoepidermoid TumorNeoplasms, NeuroepithelialEsthesioneuroblastoma, OlfactoryNeoplasms, Squamous CellPapilloma, InvertedNevi and MelanomasNeuroendocrine TumorsBreast Neoplasms, MaleOlfactory Nerve DiseasesDisease AttributesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

Inclusion Criteria: * 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 * 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Memorial Sloan Kettering Cancer Center

New York, United StatesSee the location
CompletedOne Study Center