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

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
tanespimycin
Sponsored by
Cancer Research UK
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  • Royal Marsden NHS Foundation Trust - Surrey

Outcomes

Primary Outcome Measures

Disease stabilization at 6 months

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2005
Last Updated
June 25, 2013
Sponsor
Cancer Research UK
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00104897
Brief Title
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Malignant Melanoma
Official Title
A Phase II Trial to Assess the Activity of 17-allylamino, 17-demethoxygeldanamycin (17-AAG) in Patients With Metastatic (M1, M1b & M1c) Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Research UK
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Determine the antitumor activity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with metastatic malignant melanoma. Determine the progression-free rate in patients treated with this drug. Secondary Determine the toxicity profile of this drug in these patients. Determine the duration of response in patients treated with this drug. Determine the survival of patients treated with this drug. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tanespimycin
Primary Outcome Measure Information:
Title
Disease stabilization at 6 months
Secondary Outcome Measure Information:
Title
Toxicity profile as measured by NCI CTCAE version 3
Title
Response duration
Title
Survival
Title
Pharmacodynamic effects as measured by western blot, magnetic resonance spectroscopy, and enzyme-linked immunosorbent assay (ELISA) during course 1
Title
B-RAF and RAS mutation status at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Eisen
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20683637
Citation
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.
Results Reference
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17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Malignant Melanoma

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