17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Stage III or Stage IV Melanoma
This study is currently recruiting patients.
Sponsored by: |
Memorial Sloan-Kettering Cancer Center
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
RATIONALE: Antitumor antibiotics such as 17-N-allylamino-17-demethoxygeldanamycin may stop the growth of melanoma by stopping
blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of 17-N-allylamino-17-demethoxygeldanamycin in treating patients who have
stage III or stage IV melanoma.
Condition
|
Treatment or Intervention |
Phase |
stage III melanoma Stage IV Melanoma Recurrent Melanoma
|
Drug: 17-N-allylamino-17-demethoxygeldanamycin Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: growth factor antagonist therapy
|
Phase II
|
MedlinePlus related topics: Melanoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of 17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Patients With Stage III or IV Melanoma
Further Study Details:
OBJECTIVES:
- Determine the measurable antitumor effects of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with stage III
or IV melanoma.
- Determine clinical response in patients treated with this drug.
- Determine whether this drug disrupts the MAPK pathway by depleting intratumor stores of RAF kinases and/or downstream proteins,
such as phospho-ERK, CDK4, or cyclin D1, in these patients.
- Correlate the effects of this drug with the presence of mutated BRAF within the melanoma tumor of these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to presence of BRAF mutation in tumor (yes vs no).
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-2 hours once weekly for 6 weeks. Courses repeat
every 56 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study within 1.5-2.5 years.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS: Age
Performance status
- Karnofsky 60-100% OR
- ECOG 0-2
Life expectancy
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- WBC ≥ 3,000/mm^3
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal
Renal
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- 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
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
- 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
Endocrine therapy
Radiotherapy
- Prior radiotherapy dose ≤ 3,000 cGy to fields including substantial marrow
- More than 4 weeks since prior radiotherapy and recovered
Surgery
- See Disease Characteristics
Other
- No concurrent combination antiretroviral therapy for HIV-positive patients
- 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 chamomila (chamomile)
- Glycyrrhiza glabra (licorice)
- Dillapiol
- Hypericin
- Naringin
- No other concurrent herbal extracts
Location
and Contact
Information
Florida H. Lee Moffitt Cancer Center and Research Institute, Tampa,
Florida,
33612-9497,
United States; Recruiting
Adil Daud, MD
813-558-1698
New Jersey Cancer Institute of New Jersey at Robert Wood Johnson University Hospital, New Brunswick,
New Jersey,
08903,
United States; Recruiting
James S. Goydos, MD
732-235-7563
New York Memorial Sloan-Kettering Cancer Center, New York,
New York,
10021,
United States; Recruiting
Jedd D. Wolchok, MD
212-639-6570
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,
New York,
10016,
United States; Recruiting
Study chairs or principal investigators
Paul B. Chapman, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000374980; MSKCC-04056; NCI-6480
Record last reviewed:
August 2004
Record first received:
July 8, 2004
ClinicalTrials.gov Identifier:
NCT00087386Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22