Temozolomide and Bevacizumab in Treating Patients With Metastatic Melanoma of the Eye

NCT01217398 | Unknown Phase 2

• 4 other identifiers: CDR0000683852CLCC-IC-2009-01EUDRACT-2009-011751-46EU-21063
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying giving temozolomide together with bevacizumab to see how well they work in treating patients with metastatic melanoma of the eye.

Conditions

Intraocular Melanoma

Keywords

ciliary body and choroid melanoma, medium/large size; ciliary body and choroid melanoma, small size; iris melanoma; metastatic intraocular melanoma; stage IV intraocular melanoma

Outcome Measures

Primary Outcomes (1)

• Disease control rate, in terms of objective response rate and the stable disease rate determined according to RECIST criteria at 6 months

Secondary Outcomes (6)

• Response rate

• Duration of response

• Progression-free survival

• Overall survival

• Safety of this regimen in these patients

Interventions

bevacizumab BIOLOGICAL

temozolomide DRUG

polymorphism analysis GENETIC

pharmacogenomic studies OTHER

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed uveal melanoma * Metastatic disease * Measurable disease, defined as ≥ 1 measurable lesion as measured by RECIST criteria * No curative surgical treatment envisaged * No active brain metastases (if clinical suspicion, must have a brain CT scan within 28 days) PATIENT CHARACTERISTICS: * WHO performance status (PS) 0-1 OR Karnofsky PS 70-100% * Life expectancy ≥ 12 weeks * Hemoglobin ≥ 10 g/dL * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 50 mL/min * Proteinuria \< 2+ on urinary dipstick OR 24-hour proteinuria ≤ 1 g * Total bilirubin ≤ 1.5 times ULN * AST/ALT ≤ 2.5 times ULN * Lactate dehydrogenase ≤ 5 times ULN * INR and PT ≤ 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * No uncontrolled active disease or at risk of bleeding, ongoing infection, or clotting disorder * No other cancer except for skin carcinomas and cervical carcinoma in situ * No pre-existing peripheral neuropathy, \> grade 2 (NCI CTC-AE) * No failure to comply with the medical follow-up of the study for geographical, social, or psychological reasons * No recent thrombophlebitis or pulmonary embolism within the past 6 months * No uncontrolled hypertension (systolic BP \> 150 mm Hg and/or diastolic BP \> 100 mm Hg) * No concurrent active cardiovascular disease, uncontrolled by medical treatment within the past 6 months, including any of the following: * Unstable angina * Severe hypertension * Severe arrhythmia * No unhealed wound, active peptic ulcer, bone fracture, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * No known hypersensitivity to bevacizumab, temozolomide, or their excipients PRIOR CONCURRENT THERAPY: * No prior chemotherapy for metastatic disease * At least 24 hours since insertion of central infusion port * More than 5 days since prior non-hepatic biopsy or aspiration cytology * More than 10 days since prior aspirin (\> 325 mg/day), clopidogrel (\> 75 mg/day), or full-dose oral or parenteral anticoagulant therapy, except prophylactic anticoagulant therapy prior to inclusion in the study * More than 14 days since prior laparoscopic liver biopsy * More than 28 days since prior major surgery * More than 28 days since prior participation in another study with experimental treatment * No other concurrent anticancer treatment

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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie Hopital

Paris, 75248, France

RECRUITING

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Bevacizumab; Temozolomide; Amplified Fragment Length Polymorphism Analysis; Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; DNA Fingerprinting; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Sophie Piperno-Neumann, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 8, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2012
• Last Updated: August 26, 2013

Record last verified: 2012-08

Locations

FR (1)