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Geldanamycin Analogue in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma (AAG)
This study has been completed.

First Received on July 11, 2001.   Last Updated on February 22, 2011   History of Changes
Sponsor: University of Nebraska
Collaborator: National Cancer Institute (NCI)
Information provided by: University of Nebraska
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: Primary Purpose: 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 University of Nebraska:

Estimated Enrollment: 45
Study Start Date: August 1999
Study Completion Date: April 2010
Primary Completion Date: April 2010 (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
Omaha, Nebraska, United States, 68198-6805
Sponsors and Collaborators
University of Nebraska
Investigators
Study Chair: Jean L. Grem, MD University of Nebraska
  More Information

No publications provided

Responsible Party: Jean Grem, M.D., UNMC Eppley Cancer Center at the University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00019708     History of Changes
Obsolete Identifiers: NCT00001804
Other Study ID Numbers: 170-04, P30CA036727, UNMC 170-04, MB-NAVY-98-10, NCI-T98-0075, NCI-99-C-0054
Study First Received: July 11, 2001
Last Updated: February 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Nebraska:
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012