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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   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: January 9, 2009   History of Changes

July 11, 2001
January 9, 2009
August 1999
December 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00019708 on ClinicalTrials.gov Archive Site
 
 
 
Geldanamycin Analogue in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
A Phase I and Pharmacologic Study of 17-(Allylamino)-17-Demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients With Solid Tumors

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.

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.

Phase I
Interventional
Treatment
  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: tanespimycin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
45
 
December 2008   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
 
United States
 
NCT00019708
 
CDR0000066965, UNMC 170-04, MB-NAVY-98-10, NCI-T98-0075, NCI-99-C-0054
University of Nebraska
National Cancer Institute (NCI)
Study Chair: Jean L. Grem, MD University of Nebraska
National Cancer Institute (NCI)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP