17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma
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ClinicalTrials.gov Identifier: NCT00004241 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Last Update Posted
: February 7, 2013
|
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Condition or disease | Intervention/treatment | 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 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Trial of Weekly 17-Allylamino-17 Demethoxygeldanamycin |
Study Start Date : | October 1999 |
Actual Primary Completion Date : | May 2006 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004241
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15232 |
Principal Investigator: | Ramesh Ramanathan | University of Pittsburgh |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004241 History of Changes |
Other Study ID Numbers: |
NCI-2012-02315 PCI-99-020 U01CA099168 ( U.S. NIH Grant/Contract ) CDR0000067486 ( Registry Identifier: PDQ (Physician Data Query) ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | February 7, 2013 |
Last Verified: | February 2013 |
Additional relevant MeSH terms:
Lymphoma Syndrome Leukemia Lymphoma, Follicular Sarcoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Hodgkin Disease Lymphoma, Mantle-Cell Lymphoma, B-Cell, Marginal Zone Leukemia, Lymphocytic, Chronic, B-Cell Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, Large B-Cell, Diffuse Burkitt Lymphoma Lymphoma, T-Cell |
Lymphoma, Large-Cell, Immunoblastic Plasmablastic Lymphoma Mycoses Mycosis Fungoides Sezary Syndrome Lymphoma, T-Cell, Cutaneous Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Osteosarcoma Lymphoma, Large-Cell, Anaplastic Sarcoma, Ewing Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Immunoblastic Lymphadenopathy Neuroectodermal Tumors, Primitive, Peripheral |