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

Purpose

Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. 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
AIDS-related Peripheral/Systemic Lymphoma AIDS-related Primary CNS Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Chondrosarcoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Intraocular Lymphoma Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Metastatic Osteosarcoma Nodal Marginal Zone B-cell Lymphoma Ovarian Sarcoma Primary Central Nervous System Non-Hodgkin Lymphoma 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 Adult Soft Tissue Sarcoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Osteosarcoma Recurrent Small Lymphocytic Lymphoma Recurrent Uterine Sarcoma Small Intestine Lymphoma Splenic Marginal Zone Lymphoma Stage IV Adult Burkitt Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Mixed Cell Lymphoma Stage IV Adult Diffuse Small Cleaved Cell Lymphoma Stage IV Adult Hodgkin Lymphoma Stage IV Adult Immunoblastic Large Cell Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Adult Soft Tissue Sarcoma Stage IV Adult T-cell Leukemia/Lymphoma Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Marginal Zone Lymphoma Stage IV Mycosis Fungoides/Sezary Syndrome Stage IV Small Lymphocytic Lymphoma Stage IV Uterine Sarcoma Unspecified Adult Solid Tumor, Protocol Specific	Drug: tanespimycin Other: pharmacological study	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Trial of Weekly 17-Allylamino-17 Demethoxygeldanamycin

Resource links provided by NLM:

Genetics Home Reference related topics: Ewing sarcoma Sézary syndrome mycosis fungoides

MedlinePlus related topics: Cancer Fungal Infections Lymphoma Soft Tissue Sarcoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Hodgkin Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Bone Cancer Follicular Lymphoma Lymphoma, Large-cell B-cell Lymphoma Malignant Mesenchymal Tumor Soft Tissue Sarcoma Burkitt Lymphoma Anaplastic Large Cell Lymphoma Diffuse Large B-Cell Lymphoma Mantle Cell Lymphoma Ewing Sarcoma Ewing's Family of Tumors Mycosis Fungoides Cutaneous T-cell Lymphoma Lymphoblastic Lymphoma Osteosarcoma Leukemia, T-cell, Chronic Primary Central Nervous System Lymphoma Neuroepithelioma Sezary Syndrome Chondrosarcoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Adult T-cell Leukemia/lymphoma Uterine Sarcoma Acute Lymphoblastic Leukemia

U.S. FDA Resources

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

Primary Outcome Measures:

MTD defined as the dose level preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT) assessed using Common Toxicity Criteria version 2.0 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	60
Study Start Date:	October 1999
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Schedule B (tanespimycin) Patients receive 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.	Drug: tanespimycin Given IV Other Name: 17-AAG Other: pharmacological study Correlative studies Other Name: pharmacological studies
Experimental: Schedule C (tanespimycin) 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.	Drug: tanespimycin Given IV Other Name: 17-AAG Other: pharmacological study Correlative studies Other Name: pharmacological studies

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.

II. Determine the significant toxic effects associated with this drug in these patients.

III. Determine the response in patients treated with this drug. IV. 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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed advanced epithelial cancer, malignant lymphoma, or sarcoma for which no standard curative therapy exists
Brain metastases allowed after definitive radiotherapy
Performance status - ECOG 0-2
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 mg/dL
SGOT no greater than 2 times normal
Creatinine no greater than 1.5 mg/dL
Creatinine clearance at least 60 mL/min
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
At least 4 weeks since prior biologic therapy (regional or systemic)
At least 4 weeks since prior chemotherapy
See Disease Characteristics
At least 4 weeks since prior radiotherapy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004241

Locations


United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Ramesh Ramanathan	University of Pittsburgh

More Information


Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004241 History of Changes
Other Study ID Numbers:	NCI-2012-02315 PCI-99-020 U01CA099168 CDR0000067486
Study First Received:	January 28, 2000
Last Updated:	February 6, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Lymphoma Leukemia Syndrome Lymphoma, Follicular Lymphoma, Non-Hodgkin Sarcoma Hodgkin Disease Lymphoma, B-Cell Lymphoma, Mantle-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Large B-Cell, Diffuse Leukemia, Lymphocytic, Chronic, B-Cell Precursor Cell Lymphoblastic Leukemia-Lymphoma Burkitt Lymphoma Lymphoma, Large-Cell, Immunoblastic	Plasmablastic Lymphoma Lymphoma, T-Cell Mycoses Mycosis Fungoides Sezary Syndrome Lymphoma, T-Cell, Cutaneous Leukemia, T-Cell Osteosarcoma Lymphoma, Large-Cell, Anaplastic Leukemia-Lymphoma, Adult T-Cell Sarcoma, Ewing Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Immunoblastic Lymphadenopathy Neuroectodermal Tumors, Primitive, Peripheral

ClinicalTrials.gov processed this record on September 29, 2016