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17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
This study has been completed.
First Received: December 10, 1999   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004075
  Purpose

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

PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with solid tumors that cannot be removed by surgery.


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

MedlinePlus related topics: Cancer Lymphoma Surgery
Drug Information available for: 17-(Allylamino)-17-demethoxygeldanamycin IPI-504
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Trial of 17-Allylaminogeldanamycin (17-AAG) in Solid Tumor and Lymphoma Patients

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

Study Start Date: August 1999
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), administered at 2 different dosing schedules, in patients with unresectable solid tumors.
  • Determine the pharmacokinetics of this drug in these patients.
  • Assess the effect of this drug on heat shock protein chaperone complex components and client proteins in lymphoma tissue obtained pre- and post-treatment in patients with relapsed lymphoma.
  • Determine any response to this drug in these patients.

OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 treatment groups.

  • Group I: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Group II: Patients receive 17-AAG IV over 1 hour on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 solid tumor patients receive escalating doses of 17-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, 10 patients with either lymphoma or superficial solid tumors accessible for biopsy are treated as in group II at the MTD.

Patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 58-130 patients (30-72 for group I and 28-58 for group II) will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • One of the following diagnoses:

    • Histologically or cytologically confirmed solid tumor*

      • Unresectable disease
    • Hodgkin's or non-Hodgkin's lymphoma

      • Relapsed disease
      • Failed at least 1 prior therapy
      • Neoplastic cells are accessible through biopsy NOTE: *Only patients with biopsy-accessible superficial tumors or lymphoma are eligible once the maximum tolerated dose has been determined
  • No known standard therapy that is potentially curative or definitely capable of extending life expectancy exists
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver involvement)

Renal:

  • Creatinine no greater than 1.25 times ULN OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No uncontrolled infection
  • No seizure disorder
  • No history of serious allergic reaction to eggs

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior biologic therapy
  • No concurrent immunotherapy
  • No concurrent routine or prophylactic use of a colony-stimulating factor (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])

Chemotherapy:

  • More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered from acute and reversible toxic effects
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent birth control pills
  • No concurrent steroids as anti-emetics

Radiotherapy:

  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to more than 25% of the bone marrow
  • No prior radiopharmaceuticals
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No concurrent 3A4 enzyme inhibitors (e.g., verapamil, erythromycin, miconazole, or ketoconazole)
  • No concurrent investigational ancillary therapy
  • No concurrent enrollment in another study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy approaches, or gene therapy) for symptom control or therapeutic intent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004075

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Charles Erlichman, MD Mayo Clinic
Investigator: David O. Toft, PhD Mayo Clinic
Investigator: Joel M. Reid, PhD Mayo Clinic
Investigator: Matthew M. Ames, PhD Mayo Clinic
Investigator: Thomas E. Witzig, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067283, MAYO-990102, NCI-T99-0058
Study First Received: December 10, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004075     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent mycosis fungoides/Sezary syndrome
recurrent adult grade III lymphomatoid granulomatosis
recurrent marginal zone lymphoma
recurrent small lymphocytic 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, Mantle-Cell
Lymphoma, Follicular
Mantle Cell Lymphoma
Sezary Syndrome
Lymphoma, B-Cell, Marginal Zone
Mycosis Fungoides
Lymphoblastic Lymphoma
Follicular Lymphoma
Lymphoma, Large-cell, Immunoblastic
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia
Mycoses
Cutaneous T-cell Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Large-cell
Leukemia, B-cell, Chronic
Hodgkin Disease
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphomatoid Granulomatosis
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Leukemia-Lymphoma, Adult T-Cell
Hodgkin's Disease
Recurrence
Burkitt's Lymphoma
Lymphatic Diseases

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 May 07, 2009