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
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