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17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma
This study has been completed.
First Received: January 28, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: UPMC Cancer Centers
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004241
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer 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 advanced epithelial cancer, malignant lymphoma, or sarcoma.


Condition Intervention Phase
Lymphoma
Ovarian Cancer
Sarcoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
 Drug: tanespimycin
 Phase I

MedlinePlus related topics: Cancer Intestinal Cancer Lymphoma Ovarian Cancer Soft Tissue Sarcoma
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 Weekly 17-Allylamino-17 Demethoxygeldanamycin

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

Study Start Date: December 1999
Detailed Description:

OBJECTIVES:

  • Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with advanced epithelial cancer, malignant lymphoma, or sarcoma.
  • Determine the significant toxic effects associated with this drug in these patients.
  • Determine the response in patients treated with this drug.
  • Determine the pharmacokinetics of 17-AAG and 17AG in these patients.

OUTLINE: This is a dose-escalation study. Patients receive treatment according to 1 of 2 schedules.

  • Schedule B: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-2 hours twice weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Schedule C: Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. In both schedules, cohorts of 3-6 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. At least 6 patients receive treatment at the MTD.

PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced epithelial cancer, malignant lymphoma, or sarcoma for which no standard curative therapy exists
  • Brain metastases allowed after definitive radiotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 2 times normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for at least 1 week before, during, and for at least 2 weeks after study completion
  • No active infection
  • No other serious concurrent condition
  • No prior allergic reaction to egg products

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy (regional or systemic)

Chemotherapy:

  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004241

Locations
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
UPMC Cancer Centers
National Cancer Institute (NCI)
Investigators
Study Chair: Ramesh K. Ramanathan, MD UPMC Cancer Centers
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Ramanathan RK, Egorin MJ, Eiseman JL, Ramalingam S, Friedland D, Agarwala SS, Ivy SP, Potter DM, Chatta G, Zuhowski EG, Stoller RG, Naret C, Guo J, Belani CP. Phase I and pharmacodynamic study of 17-(allylamino)-17-demethoxygeldanamycin in adult patients with refractory advanced cancers. Clin Cancer Res. 2007 Mar 15;13(6):1769-74.
Ramanathan RK, Belani CP, Friedland D, et al.: Phase I study (twice weekly schedule) of 17-allylamino-17 demethoxygeldanamycin (17AAG, NSC-704057) in patients with advanced refractory tumors. [Abstract] J Clin Oncol 23 (Suppl 16): A-3050, 204s, 2005.
Ramanathan RK, Trump DL, Eiseman JL, et al.: A phase I pharmacokinetic (PK) and pharmacodynamic (PD) trial of weekly 17-allylamino-17 demethoxygeldanamycin (17AAG, NSC-704057) in patients with advanced tumors. [Abstract] J Clin Oncol 22 (Suppl 14): A-3031, 202s, 2004.

Study ID Numbers: CDR0000067486, PCI-99-020, NCI-T99-0038
Study First Received: January 28, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004241     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent adult soft tissue sarcoma
small intestine lymphoma
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 adult T-cell leukemia/lymphoma
recurrent adult T-cell leukemia/lymphoma
primary central nervous system lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Urogenital Neoplasms
Follicular Lymphoma
Ileal Diseases
Duodenal Neoplasms
Neoplasms, Connective and Soft Tissue
Mycoses
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Anaplastic
Osteogenic Sarcoma
Neuroepithelioma
Ovarian Cancer
Hodgkin Disease
 Endocrine Gland Neoplasms
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Ewing's Sarcoma
Neuroectodermal Tumors
Malignant Mesenchymal Tumor
B-cell Lymphomas
Uterine Sarcoma
Leukemia, T-Cell
Sarcoma
Gastrointestinal Neoplasms
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:
Gastrointestinal Diseases
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Ileal Diseases
Duodenal Neoplasms
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Ileal Neoplasms
Jejunal Diseases
Lymphoma
Duodenal Diseases
Endocrine Gland Neoplasms
Jejunal Neoplasms
 Immunoproliferative Disorders
Neoplasms by Histologic Type
Ovarian Neoplasms
Digestive System Neoplasms
Immune System Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Intestinal Diseases
Intestinal Neoplasms
Adnexal Diseases
Lymphatic Diseases
Neoplasms
Digestive System Diseases
Sarcoma
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009



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