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Geldanamycin Analogue in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2007
First Received: July 11, 2001   Last Updated: January 9, 2009   History of Changes
Sponsors and Collaborators: University of Nebraska
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019708
  Purpose

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.


Condition Intervention Phase
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Drug: tanespimycin
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I and Pharmacologic Study of 17-(Allylamino)-17-Demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 45
Study Start Date: August 1999
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019708

Locations
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ     800-999-5465        
Sponsors and Collaborators
University of Nebraska
Investigators
Study Chair: Jean L. Grem, MD University of Nebraska
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066965, UNMC 170-04, MB-NAVY-98-10, NCI-T98-0075, NCI-99-C-0054
Study First Received: July 11, 2001
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00019708     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Mantle Cell Lymphoma
Lymphoma, B-Cell, Marginal Zone
Lymphoblastic Lymphoma
Follicular Lymphoma
Recurrence
Lymphoma, Large-cell, Immunoblastic
Lymphoma, Small Cleaved-cell, Diffuse
Lymphoma, B-Cell
Burkitt's Lymphoma
Lymphatic Diseases
Chronic Lymphocytic Leukemia
B-cell Lymphomas
Leukemia, Lymphocytic, Chronic, B-Cell
Burkitt Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Large-cell
Leukemia, B-cell, Chronic
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on July 02, 2009