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Tanespimycin in Treating Patients With Stage III-IV Melanoma

Primary Purpose

Recurrent Melanoma, Stage III Melanoma, Stage IV Melanoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tanespimycin
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Melanoma

Eligibility Criteria

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

Inclusion Criteria: Histologically or cytologically confirmed melanoma Stage III or IV disease No primary melanoma of the choroid or mucosa Measurable disease At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan Tumor amenable to biopsy (for the first 10 patients in each stratum only) Patients must have measurable disease in addition to the tumor(s) to be biopsied No brain or epidural metastases Completely resected solitary brain metastases allowed provided patient has been free of CNS metastases for >= 6 months Performance status - Karnofsky 60-100% Performance status - ECOG 0-2 More than 3 months Absolute neutrophil count >= 1,500/mm^3 Platelet count >= 100,000/mm^3 WBC >= 3,000/mm^3 AST and ALT =< 2.5 times upper limit of normal Creatinine normal No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No history of myocardial infarction No history of prolonged QTc interval No active ischemic heart disease within the past 12 months No uncontrolled dysrhythmia or dysrhythmias requiring medication No congenital prolonged QT syndrome No left bundle branch block Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reaction attributed to compounds of similar chemical or biological composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) No prior serious allergic reaction to eggs No other uncontrolled illness No active or ongoing infection requiring systemic antimicrobial treatment No psychiatric illness or social situation that would preclude study compliance No more than 1 prior chemotherapy regimen for metastatic melanoma Prior vaccines, cytokines, or interferon alfa is not considered prior therapy unless administered with a chemotherapy drug More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Prior radiotherapy dose =< 3,000 cGy to fields including substantial marrow More than 4 weeks since prior radiotherapy and recovered No prior radiotherapy field that included the heart (e.g., mantle) No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent medications that may prolong the QTc interval No other concurrent anticancer therapy No other concurrent investigational agents No concurrent treatment with any of the following medications or herbal remedies: Inhibitors of CYP3A4: Fluconazole Itraconazole Ketoconazole Macrolide antibiotics (azithromycin, clarithromycin, erythromycin, or troleandomycin) Midazolam Nifedipine Verapamil Diltiazem Terfenadine Cyclosporine Cisapride Inducers of CYP3A4: Carbamazepine Phenobarbital Phenytoin Rifampin Herbal extracts and tinctures with CYP3A4 inhibitory activity: Hydrastis canadensis (goldenseal) Hypericum perforatum (St. John's wort) Uncaria tomentosa (cat's claw) Echinacea angustifolia roots Trifolium pratense (wild cherry) Matricaria chamomilla (chamomile) Glycyrrhiza glabra (licorice) Dillapiol Hypericin Naringin No other concurrent herbal extracts

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (tanespimycin)

Arm Description

Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Response rate (complete and partial response)

Secondary Outcome Measures

Proportion of patients with stable disease
Frequency of toxicities

Full Information

First Posted
July 8, 2004
Last Updated
April 9, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00087386
Brief Title
Tanespimycin in Treating Patients With Stage III-IV Melanoma
Official Title
Phase II Trial of 17-N-allylamino-17-demethoxy Geldanamycin (17-AAG, NSC #330507) Diluted in EPL Diluent (NSC #704057) in Metastatic Melanoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Study Start Date
June 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase II trial is studying how well tanespimycin works in treating patients with stage III or stage IV melanoma. Antitumor antibiotics such as tanespimycin may stop the growth of melanoma by stopping blood flow to the tumor.
Detailed Description
PRIMARY OBJECTIVES: I. Determine if treatment with 17-AAG results in measurable anti-tumor effects and calculate the proportion of clinical responses. II. Test the hypothesis that treatment with 17-AAG can disrupt the MAPK pathway by depleting intra-tumor stores of RAF kinases and/or downstream proteins such as phospho-ERK, CDK4 and cyclin D1. III. Determine if either of these effects correlates with the presence of mutated BRAF within the melanoma tumor. OUTLINE: This is a multicenter study. Patients are stratified according to presence of BRAF mutation in tumor (yes vs no). Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Melanoma, Stage III Melanoma, Stage IV Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (tanespimycin)
Arm Type
Experimental
Arm Description
Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
tanespimycin
Other Intervention Name(s)
17-AAG
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate (complete and partial response)
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Proportion of patients with stable disease
Time Frame
At 1 year
Title
Frequency of toxicities
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed melanoma Stage III or IV disease No primary melanoma of the choroid or mucosa Measurable disease At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan Tumor amenable to biopsy (for the first 10 patients in each stratum only) Patients must have measurable disease in addition to the tumor(s) to be biopsied No brain or epidural metastases Completely resected solitary brain metastases allowed provided patient has been free of CNS metastases for >= 6 months Performance status - Karnofsky 60-100% Performance status - ECOG 0-2 More than 3 months Absolute neutrophil count >= 1,500/mm^3 Platelet count >= 100,000/mm^3 WBC >= 3,000/mm^3 AST and ALT =< 2.5 times upper limit of normal Creatinine normal No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No history of myocardial infarction No history of prolonged QTc interval No active ischemic heart disease within the past 12 months No uncontrolled dysrhythmia or dysrhythmias requiring medication No congenital prolonged QT syndrome No left bundle branch block Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reaction attributed to compounds of similar chemical or biological composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) No prior serious allergic reaction to eggs No other uncontrolled illness No active or ongoing infection requiring systemic antimicrobial treatment No psychiatric illness or social situation that would preclude study compliance No more than 1 prior chemotherapy regimen for metastatic melanoma Prior vaccines, cytokines, or interferon alfa is not considered prior therapy unless administered with a chemotherapy drug More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Prior radiotherapy dose =< 3,000 cGy to fields including substantial marrow More than 4 weeks since prior radiotherapy and recovered No prior radiotherapy field that included the heart (e.g., mantle) No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent medications that may prolong the QTc interval No other concurrent anticancer therapy No other concurrent investigational agents No concurrent treatment with any of the following medications or herbal remedies: Inhibitors of CYP3A4: Fluconazole Itraconazole Ketoconazole Macrolide antibiotics (azithromycin, clarithromycin, erythromycin, or troleandomycin) Midazolam Nifedipine Verapamil Diltiazem Terfenadine Cyclosporine Cisapride Inducers of CYP3A4: Carbamazepine Phenobarbital Phenytoin Rifampin Herbal extracts and tinctures with CYP3A4 inhibitory activity: Hydrastis canadensis (goldenseal) Hypericum perforatum (St. John's wort) Uncaria tomentosa (cat's claw) Echinacea angustifolia roots Trifolium pratense (wild cherry) Matricaria chamomilla (chamomile) Glycyrrhiza glabra (licorice) Dillapiol Hypericin Naringin No other concurrent herbal extracts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Chapman
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

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Tanespimycin in Treating Patients With Stage III-IV Melanoma

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