17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Malignant Melanoma

NCT00104897 | Completed Phase 2

• 3 other identifiers: CRUK-PH2/049CDR0000415352NCI-6500
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• Disease stabilization at 6 months

Secondary Outcomes (5)

• Toxicity profile as measured by NCI CTCAE version 3

• Response duration

• Survival

• 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

Interventions

tanespimycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 20683637 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Timothy Eisen

  Cambridge University Hospitals NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: March 1, 2005
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 26, 2013

Record last verified: 2008-03

Locations

GB (2)