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Geldanamycin Analogue in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

This study is currently recruiting participants.
Study NCT00019708.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Geldanamycin Analogue in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Official Title  A Phase I and Pharmacologic Study of 17-(Allylamino)-17-Demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients With Solid Tumors
Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of geldanamycin analogue in treating patients who have advanced solid tumors or non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of geldanamycin analogue (AAG) in patients with advanced solid tumors.
  • Determine the toxic effects of this drug in this patient population.
  • Determine the biochemical and molecular effects of this drug in normal and accessible tumor tissue in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Assess any antitumor activity of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive geldanamycin analogue (AAG) IV over 1-6 hours once daily on days 1, 4, 15, and 18. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of 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. Once the MTD is determined, an additional 10 patients are treated at the MTD.

Patients are followed every 6 weeks.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Intervention  Drug: tanespimycin
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  45
Start Date  August 1999
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced solid tumor for which no curative therapy exists

    • Non-Hodgkin's lymphoma allowed
  • No leukemia
  • No active CNS involvement with tumor

PATIENT CHARACTERISTICS:

Age:

  • 19 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin ≤ upper limit of normal (ULN)
  • AST no greater than 2 times ULN (no greater than 98 U/L)

Renal:

  • Creatinine ≤ ULN OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • None of the following significant cardiac diseases:

    • New York Heart Association class III or IV heart failure
    • History of myocardial infarction within the past year
    • Uncontrolled dysrhythmias
    • Poorly controlled angina
  • No serious ventricular arrhythmia (i.e., ventricular tachycardia (VT) or ventricular fibrillation (VF) ≥ 3 beats in a row)
  • QTc interval ≤ 450 msec for men or ≤ 470 msec for women
  • LVEF ≥ 40% by MUGA

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No other serious medical condition that would preclude study participation
  • No serious hypersensitivity to egg products

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent anticancer immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy and recovered
  • No other concurrent anticancer chemotherapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP] or mechlorethamine, vincristine, procarbazine, and prednisone [MOPP])

Endocrine therapy:

  • No concurrent anticancer hormonal therapy
  • No concurrent anticancer glucocorticoids

    • Concurrent glucocorticoids as antiemetics for nonmalignant disease allowed

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • No concurrent major surgery

Other:

  • No concurrent drugs that interfere with hepatic CYP3A4 metabolism (e.g., grapefruit juice, ketoconazole, fluconazole, itraconazole, cyclosporine, erythromycin, clarithromycin, cimetidine, terfenadine, astemizole, indinavir, or nelfinavir mesylate)
  • No concurrent medications that cause QTc prolongation
Gender Both
Ages 19 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00019708
Organization ID CDR0000066965
Secondary IDs †† UNMC-17004, MB-NAVY-98-10, NCI-T98-0075, NCI-99-C-0054
Study Sponsor  University of Nebraska
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Jean L. Grem, MD     University of Nebraska    
Information Provided By National Cancer Institute (NCI)
Verification Date October 2007
First Received Date  July 11, 2001
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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