17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma - Full Text View

Sponsor:	University of Pittsburgh
Collaborator:	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

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase I Trial of Weekly 17-Allylamino-17 Demethoxygeldanamycin

Resource links provided by NLM:

MedlinePlus related topics: Cancer Intestinal Cancer Leukemia Lymphoma Ovarian Cancer Soft Tissue Sarcoma

Drug Information available for: 17-(Allylamino)-17-demethoxygeldanamycin IPI-504

U.S. FDA Resources

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

University of Pittsburgh

National Cancer Institute (NCI)

Investigators

Study Chair:

Ramesh K. Ramanathan, MD

University of Pittsburgh

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.

ClinicalTrials.gov Identifier:	NCT00004241 History of Changes
Other Study ID Numbers:	CDR0000067486, PCI-99-020, NCI-T99-0038
Study First Received:	January 28, 2000
Last Updated:	March 13, 2010
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 non-Hodgkin lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Ovarian Neoplasms
Lymphoma, Large-Cell, Immunoblastic
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Intestinal Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

Immune System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Duodenal Diseases

ClinicalTrials.gov processed this record on February 12, 2012