Clinical Trial of Continuing Treatment for Patients Who Have Participated on a Prior Protocol Investigating Tanespimycin

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to provide treatment to patients who have participated on a prior protocol investigating Tanespimycin (KOS-953,17-AAG)

Official Title
-----------------
Phase 2 Clinical Trial of Tanespimycin in Patients With Advanced Malignancies After Failure of Previous Anti-cancer Therapy Regimens Who Have Participated on a Prior Protocol Investigating Tanespimycin

Conditions
-----------------
Advanced Malignancies

Intervention / Treatment
-----------------
* Drug: Tanespimycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Participated in and completed a previous Tanespimycin protocol without evidence of unacceptable toxicity and is deemed by the Investigator to be deriving benefit from the Tanespimycin drug as defined in the previous protocol All patients must rollover to this continuation protocol within 30 days of the last dose of Tanespimycin in the previous protocol, unless previously approved by the Medical Monitor All Adverse Events from the prior protocol, must have resolved to NCI CTCAE (v. 3.0) Grade <= 2 The following laboratory results, within 10 days of Tanespimycin administration: Hemoglobin >= 8 g/dL Absolute neutrophils count >= 1.0x 10*9* /L Platelet count >= 50 x 10*9* /L Serum bilirubin <= 2 x ULN AST <= 2.5 ULN Serum creatinine <= 2 x ULN ECOG performance status of 0, 1 or 2 Signed informed consent Exclusion Criteria: Pre-existing neuropathy of CTCAE Grade >= 3 due to any cause Documented hypersensitivity reaction of CTCAE Grade >= 3 to prior therapy containing Cremophor (for those patients receiving Tanespimycin Injection) Pregnant or breast-feeding women Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic), excluding Tanespimycin within 21 days prior to receipt of study medication Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: Tanespimycin<br>* Solution, IV This is a one arm study with the dose, frequency, and duration assigned as per previous protocol (KOS-953, 17-AAG)<br>* Other names: BMS-722782;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There is no Primary Outcome |  | No formal analysis of efficacy will occur | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
This is an open-label continuing treatment protocol in patients with advanced malignancies who will receive Tanespimycin