NCT00003969

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of a geldanamycin analogue in treating patients with advanced cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 1998

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

June 26, 2013

Status Verified

December 1, 2000

First QC Date

November 1, 1999

Last Update Submit

June 25, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Recommended phase II dose of 17-allylamino-17-demethoxygeldanamycin (17-AAG) at 4 weeks

Secondary Outcomes (2)

  • Heat shock protein 90 (HSP90) client protein and co-chaperone changes during first course of treatment

  • Pharmacokinetic profile of 17-AAG during the first course of treatment

Interventions

tanespimycinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically proven malignancies refractory to conventional treatment or for which no standard therapy exists * Primary brain tumor or brain metastases allowed if stable symptoms within 2 weeks prior to study and able to give informed consent PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * WHO 0-2 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10.0 g/dL * Absolute neutrophil count at least 1,500/mm\^3 Hepatic: * Bilirubin less than 1.0 mg/dL * AST and ALT no greater than 2.5 times upper limit of normal if due to liver metastases * No chronic liver disease Renal: * Creatinine less than 1.47 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No myocardial infarction within the past 6 months * No angina requiring treatment within the past 6 months * No uncompensated coronary artery disease by electrocardiogram or physical examination * No prior transient ischemic attacks, stroke, or peripheral vascular disease * LVEF at least 45% Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after study * No allergy to egg products * No nonmalignant systemic disease that would increase risk * No active uncontrolled infection * No diabetes mellitus with evidence of severe peripheral vascular disease or diabetic ulcers PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered * No other concurrent chemotherapy Endocrine therapy: * At least 4 weeks since other prior endocrine therapy and recovered * Concurrent corticosteroids for symptom control allowed if no change in dose requirement within 2 weeks prior to study Radiotherapy: * At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered * Concurrent radiotherapy allowed for control of bone pain or as indicated Surgery: * Not specified Other: * No other concurrent investigational treatment * No concurrent treatment with drugs interfering with hepatic CYP3A4 metabolism (e.g., grapefruit juice or warfarin)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden NHS Foundation Trust - London

London, England, SW3 6JJ, United Kingdom

Location

Related Publications (1)

  • Banerji U, O'Donnell A, Scurr M, Pacey S, Stapleton S, Asad Y, Simmons L, Maloney A, Raynaud F, Campbell M, Walton M, Lakhani S, Kaye S, Workman P, Judson I. Phase I pharmacokinetic and pharmacodynamic study of 17-allylamino, 17-demethoxygeldanamycin in patients with advanced malignancies. J Clin Oncol. 2005 Jun 20;23(18):4152-61. doi: 10.1200/JCO.2005.00.612.

    PMID: 15961763RESULT

MeSH Terms

Interventions

tanespimycin

Study Officials

  • Ian R. Judson, MA, MD, FRCP

    Royal Marsden NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

August 1, 1998

Study Completion

January 1, 2007

Last Updated

June 26, 2013

Record last verified: 2000-12

Locations

GB(1)