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Carboplatin and Temozolomide in Treating Patients With Unresectable or Metastatic Melanoma



Carboplatin and Temozolomide in Treating Patients With Unresectable or Metastatic Melanoma

For Condition: Recurrent Melanoma,Stage 4 Melanoma
Status: No longer recruiting
Sponsor(s): Mount Vernon Hospital ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and temozolomide in treating patients who have unresectable or metastatic melanoma.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of carboplatin and temozolomide in patients with unresectable or metastatic melanoma. II. Assess the safety of this cytotoxic combination in this patient population. III. Assess the preliminary evidence of efficacy of this combination in these patients. PROTOCOL OUTLINE: This is an open label, dose escalation study. Patients receive oral temozolomide once daily on days 1-5. Carboplatin IV is administered over 1 hour on day 1. Courses are repeated every 28 days. Treatment continues for a maximum of 6 courses in the absence of toxicity and disease progression. Sequential dose escalation of carboplatin with a fixed dose of temozolomide is followed by sequential dose escalation of carboplatin at a higher fixed dose of temozolomide. Dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxic effects. If the combination treatment with carboplatin given on day 1 of temozolomide therapy is more toxic than anticipated, then the study is repeated with carboplatin given on day 5 of temozolomide therapy. Patients are followed at least every 2 months. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven unresectable or metastatic melanoma --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior biologic therapy and recovered; No concurrent biologic therapy - Chemotherapy: At least 4 weeks since prior chemotherapy and recovered; No prior carboplatin and temozolomide; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; At least 3 weeks since prior palliative radiotherapy; No concurrent radiotherapy - Surgery: No concurrent surgery to tumor - Other: No other concurrent investigational agent --Patient Characteristics-- - Age: Over 18 - Performance status: ECOG 0-2 - Life expectancy: Greater than 3 months - Hematopoietic: Hemoglobin greater than 10 g/dL; WBC greater than 3,000/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin less than 1.8 mg/dL; AST less than 3 times upper limit of normal (ULN); Alkaline phosphatase less than 3 times ULN; No hepatitis B - Renal: Creatinine less than 1.4 mg/dL OR Creatinine clearance greater than 50 mL/min - Cardiovascular: No New York Heart Association class II cardiac disease - Pulmonary: No pulmonary disease requiring oxygen therapy - Other: Not pregnant; Fertile patients must use effective contraception during study and for 3 months following; No concurrent serious nonmalignant disease; No AIDS; No uncontrolled infection; No uncontrolled diabetes; No medical condition that will interfere with taking oral temozolomide
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
GordonSampson Rustin,  Study Chair,  Mount Vernon Hospital

Mount Vernon Hospital
Northwood,  England,  HA6 2RN
United Kingdom
 


Additional Information:
Study ID Numbers:  CDR0000066867;  MTVERNHOSP-OCT1998,EU-98069
Study Start Date: October 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003747

Other Stage 4 Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Stage IV Melanoma

2. Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver

3. CCI-779 in Treating Patients With Metastatic Melanoma

4. Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma

5. Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma

Related Studies:

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Carboplatin and Temozolomide in Treating Patients With Unresectable or Metastatic Melanoma
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