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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000415352 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-6500 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic malignant melanoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses of treatment, disease response is assessed. Patients with stable or responding disease receive additional courses of treatment.
After completion of study treatment, patients are followed at 28 days and then every 3 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 12-18 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tanespimycin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Disease stabilization at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity profile as measured by NCI CTCAE version 3 | ||
| Response duration | ||
| Survival |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant melanoma
Measurable disease by clinical exam, x-ray, CT scan, or MRI
Must have documented disease progression at 2 time points separated by ≥ 6 months
No primary brain tumors or brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Recovered from all prior therapy
No concurrent therapeutic anticoagulation with warfarin
No other concurrent anticancer therapy
No other concurrent investigational drugs
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Eisen | Cambridge University Hospitals NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | Cambridge | England | CB2 2QQ | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20683637 | Result | Pacey S, Gore M, Chao D, Banerji U, Larkin J, Sarker S, Owen K, Asad Y, Raynaud F, Walton M, Judson I, Workman P, Eisen T. A Phase II trial of 17-allylamino, 17-demethoxygeldanamycin (17-AAG, tanespimycin) in patients with metastatic melanoma. Invest New Drugs. 2012 Feb;30(1):341-9. doi: 10.1007/s10637-010-9493-4. Epub 2010 Aug 5. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C112765 | tanespimycin |
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| Pharmacodynamic effects as measured by western blot, magnetic resonance spectroscopy, and enzyme-linked immunosorbent assay (ELISA) during course 1 |
| B-RAF and RAS mutation status at baseline |
| Royal Marsden NHS Foundation Trust - Surrey |
| Sutton |
| England |
| SM2 5PT |
| United Kingdom |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |