17-Dimethylaminoethylamino-17-Demethoxygeldanamycin (17-DMAG) in Treating Patients With Metastatic Solid Tumors or Tumors That Cannot Be Removed By Surgery

NCT00248521 | Unknown Phase 1

• 3 other identifiers: ICR-PH1/102CDR0000442402NCI-6547
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic solid tumors or tumors that cannot be removed by surgery.

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-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) at 28 days after treatment

Secondary Outcomes (3)

• Heat shock protein 90 (HSP90) client protein and co-chaperone changes up to 29 days after treatment

• Tumor response by RECIST criteria every 6 weeks while on study

• Clinical pharmacokinetic profile established during the first course of treatment

Interventions

alvespimycin hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor * Unresectable or metastatic disease * Standard curative or palliative measures do not exist OR are no longer effective OR patient refused such measures * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * More than 12 weeks Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL Hepatic * Bilirubin normal * ALT and AST ≤ 1.5 times upper limit of normal * No chronic liver disease * Hepatitis B or C negative Renal * Creatinine normal OR * Creatinine clearance normal Cardiovascular * No symptomatic New York Heart Association class III-IV cardiac disease * No myocardial infarction within the past year * No active ischemic heart disease within the past year * No poorly controlled angina * No uncontrolled dysrhythmia or dysrhythmias requiring antiarrhythmic drugs * No transient ischemic attack * No stroke * No peripheral vascular disease * No congenital long QT syndrome * No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) * QTc \< 450 msec (for men) and 470 msec (for woman) * LVEF \> 40% by MUGA * No left bundle branch block Pulmonary * No symptomatic pulmonary disease requiring medication, including any of the following: * Dyspnea with or without exertion * Paroxysmal nocturnal dyspnea * Oxygen requirement * Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception 4 weeks before, during, and for 6 months after completion of study treatment * No known HIV positivity * No other malignancy within the past 5 years except adequately treated cone biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * No ongoing or active infection * No diabetes mellitus (with evidence of severe peripheral vascular disease or ulcers) * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy * Concurrent epoetin alfa allowed Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No prior 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) Endocrine therapy * More than 4 weeks since prior endocrine therapy * Concurrent luteinizing hormone-releasing hormone analogues for androgen-insensitive prostate cancer and rising prostate-specific antigen allowed Radiotherapy * More than 4 weeks since prior radiotherapy (except for palliative treatment) * No prior irradiation field that potentially included the heart (e.g., mantle) Surgery * Not specified Other * Recovered from all prior therapy * Concurrent bisphosphonates allowed * At least 5 half-lives since prior and no concurrent medication that prolong QTc * No other concurrent anticancer or investigational agents * No concurrent grapefruit juice

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

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Institute of Cancer Research - Sutton

Sutton, England, SM2 5NG, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Belfast City Hospital Trust Incorporating Belvoir Park Hospital

Belfast, Northern Ireland, BT8 8JR, United Kingdom

Location

Related Publications (1)

• Pacey SC, Wilson RH, Walton M, et al.: A phase I trial of the heat shock protein 90 (HSP90) inhibitor alvespimycin (17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG) administered weekly, intravenously, to patients with advanced solid tumors. [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-PR-6, 2007.

  RESULT

Study Officials

• Ian R. Judson, MA, MD, FRCP

  Institute of Cancer Research, United Kingdom

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 4, 2005
• Study Start: October 1, 2005
• Primary Completion: January 1, 2007
• Last Updated: August 2, 2013

Record last verified: 2008-03

Locations

GB (3)