Completed

A Phase I Study Of 17-Dimethylaminoethylamino-17-Demethoxygeldanamycin, (17-DMAG) (NSC 707545) In Patients With Advanced Solid Tumors

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What is being tested

alvespimycin hydrochloride

+ laboratory biomarker analysis

DrugOther
Who is being recruted

Lymphadenopathy+51

+ Bacterial Infections and Mycoses

+ Blood Protein Disorders

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: January 13, 2026
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 maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with metastatic or unresectable solid tumors or lymphomas. II. Determine the safety and toxicity of this drug in these patients. III. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. IV. Determine the recommended phase II dose of this drug for future studies. SECONDARY OBJECTIVES: I. Determine tumor response in patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-6 hours on days 1-3 or 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-2 patients receive accelerated escalating doses of 17-DMAG 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 17-DMAG 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. Patients are followed at 4 weeks.

Official TitleA Phase I Study Of 17-Dimethylaminoethylamino-17-Demethoxygeldanamycin, (17-DMAG) (NSC 707545) In Patients With Advanced Solid Tumors 
NCT00089271
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 13, 2026
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

60 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

LymphadenopathyBacterial Infections and MycosesBlood Protein DisordersBurkitt LymphomaCardiovascular DiseasesChronic DiseaseDiseaseDNA Virus InfectionsEye NeoplasmsHematologic DiseasesHemorrhagic DisordersHerpesviridae InfectionsHodgkin DiseaseImmunoblastic LymphadenopathyImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoproliferative DisordersWaldenstrom MacroglobulinemiaMycosesMycosis FungoidesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteParaproteinemiasPathologic ProcessesRecurrenceSezary SyndromeSyndromeTumor Virus InfectionsVascular DiseasesVirus DiseasesLeukemia, B-CellLeukemia, Lymphocytic, Chronic, B-CellLeukemia, T-CellLeukemia-Lymphoma, Adult T-CellLymphoma, B-CellLymphoma, T-CellLymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, CutaneousLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal ZoneEpstein-Barr Virus InfectionsHemostatic DisordersLymphoma, Mantle-CellDisease AttributesNeoplasms, Plasma CellIntraocular Lymphoma

Criteria

Inclusion Criteria: * Histologically confirmed solid tumor or lymphoma * Metastatic or unresectable disease * Standard curative or palliative measures do not exist or are no longer effective * No known brain metastases * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * More than 12 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * ALT and AST ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ normal * Creatinine ≤ 1.25 times ULN * Creatinine clearance ≥ 60 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 or active ischemic heart disease within the past year * No New York Heart Association class III or IV congestive heart failure * No poorly controlled angina * No uncontrolled dysrhythmia requiring medication * No left bundle branch block * No history of congenital long QT syndrome * No other significant cardiac disease * Pulse oximetry at rest or on exercise \> 88% * No symptomatic pulmonary disease (e.g., chronic obstructive or restrictive pulmonary disease, etc.) or any of the following are allowed: * Pulmonary disease requiring medication * History of dyspnea, dyspnea on exertion, or paroxysmal nocturnal dyspnea * Patients meeting the Medicare criteria for home oxygen or are on oxygen * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double barrier contraception 1 week before, during, and for at least 2 weeks after study participation * No uncontrolled illness * No active or ongoing infection * No history of allergic reaction attributed to compounds of similar chemical or biological composition to 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) * No psychiatric illness or social situation that would preclude study compliance * No concurrent routine colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Concurrent hormonal therapy allowed * At least 4 weeks since prior radiotherapy and recovered * No prior radiation that included the heart in the field (e.g., mantle) * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer agents or therapies * No concurrent medication that would prolong the QTc interval * No other concurrent investigational agents

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 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-6 hours on days 1-3 or 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary 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

University of Pittsburgh

Pittsburgh, United StatesSee the location
CompletedOne Study Center