Completed

A Phase I Trial of Weekly 17-Allylamino-17 Demethoxygeldanamycin

What is being tested

tanespimycin

+ pharmacological study

+ tanespimycin

DrugOther

Who is being recruted

Lymphadenopathy+54

+ Chronic Disease

+ DNA Virus Infections

Over 18 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: October 1999

See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)

Last updated: February 7, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1999

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with advanced epithelial cancer, malignant lymphoma, or sarcoma. II. Determine the significant toxic effects associated with this drug in these patients. III. Determine the response in patients treated with this drug. IV. Determine the pharmacokinetics of 17-AAG and 17AG in these patients. OUTLINE: This is a dose-escalation study. Patients receive treatment according to 1 of 2 schedules. Schedule B: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-2 hours twice weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Schedule C: Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. In both schedules, cohorts of 3-6 patients 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 6 patients experience dose-limiting toxicity. At least 6 patients receive treatment at the MTD. PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.

NCT00004241

Principal SponsorNational Cancer Institute (NCI)

Last updated: February 7, 2013

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

LymphadenopathyChronic DiseaseDNA Virus InfectionsEye NeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Connective TissueNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissuePathologic ProcessesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVirus DiseasesLeukemia, B-CellLymphoma, B-CellLymphoma, T-CellNeuroectodermal TumorsNeoplasms, Connective and Soft TissueNeoplasms, Bone TissueNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialEpstein-Barr Virus InfectionsDisease AttributesBurkitt LymphomaChondrosarcomaHodgkin DiseaseImmunoblastic LymphadenopathyLymphoma, FollicularLymphoma, Non-HodgkinMycosis FungoidesSarcomaOsteosarcomaSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, CutaneousLymphoma, Large-Cell, AnaplasticNeuroectodermal Tumors, Primitive, PeripheralLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular Lymphoma

Criteria

19 inclusion criteria required to participate

At least 4 weeks since prior chemotherapy

No prior allergic reaction to egg products

Creatinine clearance at least 60 mL/min

At least 4 weeks since prior biologic therapy (regional or systemic)

Show More Criteria

Study Plan

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

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Patients receive 17-AAG IV over 1-2 hours twice weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Group II

Experimental

Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

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

University of Pittsburgh

Pittsburgh, United StatesOpen University of Pittsburgh in Google Maps

CompletedOne Study Center