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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00004241

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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 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

Detailed Description

PRIMARY 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. 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 Design

Study Type:

Interventional

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 :

Oct 1, 1999

Actual Primary Completion Date :

May 1, 2006

Arms and Interventions

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 Names: 17-AAG Other: pharmacological study Correlative studies Other Names: 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 Names: 17-AAG Other: pharmacological study Correlative studies Other Names: pharmacological studies

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 Names:

17-AAG

Other: pharmacological study

Correlative studies

Other Names:

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 Names:

17-AAG

Other: pharmacological study

Correlative studies

Other Names:

pharmacological studies

Outcome Measures

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 [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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