Clinical trial · Interventional
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Malignant Melanoma
A Phase II Trial to Assess the Activity of 17-allylamino, 17-demethoxygeldanamycin (17-AAG) in Patients With Metastatic (M1, M1b & M1c) Malignant Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tanespimycin | Drug | Tanespimycin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease stabilization at 6 months
Secondary outcomes (5)
- measure
- Toxicity profile as measured by NCI CTCAE version 3
- measure
- Response duration
- measure
- Survival
- measure
- Pharmacodynamic effects as measured by western blot, magnetic resonance spectroscopy, and enzyme-linked immunosorbent assay (ELISA) during course 1
- measure
- B-RAF and RAS mutation status at baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant melanoma * Metastatic (M1a, M1b, or M1c) disease * Measurable disease by clinical exam, x-ray, CT scan, or MRI * Must have documented disease progression at 2 time points separated by ≥ 6 months * Pre-existing visceral lesions or the appearance of new visceral lesions allowed * New skin disease amenable to surgery not allowed * No primary brain tumors or brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 9.0 g/dL Hepatic * Bilirubin normal * ALT and AST ≤ 1.5 times upper limit of normal * No chronic liver disease * No known hepatitis B or C positivity Renal * Creatinine \< 130 mmol/L OR * Creatinine clearance \> 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No myocardial infarction within the past 6 months * No unstable angina pectoris * No cardiac arrhythmia * No transient ischemic attack * No stroke or peripheral vascular disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 4 weeks before, during, and for 6 months after study participation * No ongoing or active infection * No diabetes mellitus with evidence of severe peripheral vascular disease or ulcers * No history of allergy to eggs * No known HIV positivity * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * No other malignancy except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * More than 4 weeks since prior endocrine therapy * Concurrent steroids allowed provided they are given at the lowest possible maintenance dose Radiotherapy * More than 4 weeks since prior radiotherapy unless administered for palliative care * Concurrent radiotherapy allowed provided it is administered as a single fraction for bone pain OR as indicated for palliative care Surgery * Not specified Other * Recovered from all prior therapy * Alopecia allowed * No concurrent therapeutic anticoagulation with warfarin * Concurrent prophylactic warfarin for central line maintenance allowed provided INR is checked regularly until stable * Concurrent low-molecular weight heparin allowed * No other concurrent anticancer therapy * No other concurrent investigational drugs
References
Publications (1)
- RESULTPacey 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. PMID 20683637