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Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma

Primary Purpose

Intraocular Melanoma, Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pegylated interferon alfa
temozolomide
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraocular Melanoma focused on measuring iris melanoma, extraocular extension melanoma, recurrent intraocular melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma Unresectable stage III or stage IV disease Ocular, mucosal, or cutaneous melanoma Measurable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of severe cardiovascular disease No myocardial infarction within the past 6 months No unstable angina No New York Heart Association class III or IV heart disease (congestive heart failure) No ventricular tachyarrhythmias Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No AIDS-related illness No frequent vomiting or other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction) No serious infection requiring IV antibiotics No psychiatric disorder requiring ongoing therapy or medication No nonmalignant illness or other medical condition that would preclude study No other active malignancy within the past 2 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer detected initially during transurethral resection of the prostate (TURP) (comprising less than 5% of resected tissue) with PSA level normal since TURP PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy and recovered No concurrent immunotherapy Chemotherapy: No prior dacarbazine No prior temozolomide No other concurrent chemotherapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 3 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery At least 3 weeks since prior radiotherapy to the brain for brain metastases Prior radiotherapy to indicator lesions allowed if there is evidence of disease progression Recovered from prior radiotherapy No concurrent radiotherapy Surgery: At least 2 weeks since prior surgical procedure requiring general anesthesia and recovered

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 7, 2001
Last Updated
June 4, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00027742
Brief Title
Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma
Official Title
A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.
Detailed Description
OBJECTIVES: Determine the response rate in patients with advanced melanoma treated with temozolomide and pegylated interferon alfa. Determine the toxicity profile of this regimen in these patients. Determine the duration of disease response and overall survival of patients treated with this regimen. OUTLINE: Patients are stratified according to CNS metastases (yes vs no). Patients receive oral temozolomide once daily on weeks 1-6 and pegylated interferon alfa subcutaneously once weekly on weeks 1-8. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 23-61 patients (12-35 without CNS metastases and 11-26 with CNS metastases) will be accrued for this study within 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Melanoma, Melanoma (Skin)
Keywords
iris melanoma, extraocular extension melanoma, recurrent intraocular melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
pegylated interferon alfa
Intervention Type
Drug
Intervention Name(s)
temozolomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma Unresectable stage III or stage IV disease Ocular, mucosal, or cutaneous melanoma Measurable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of severe cardiovascular disease No myocardial infarction within the past 6 months No unstable angina No New York Heart Association class III or IV heart disease (congestive heart failure) No ventricular tachyarrhythmias Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No AIDS-related illness No frequent vomiting or other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction) No serious infection requiring IV antibiotics No psychiatric disorder requiring ongoing therapy or medication No nonmalignant illness or other medical condition that would preclude study No other active malignancy within the past 2 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer detected initially during transurethral resection of the prostate (TURP) (comprising less than 5% of resected tissue) with PSA level normal since TURP PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy and recovered No concurrent immunotherapy Chemotherapy: No prior dacarbazine No prior temozolomide No other concurrent chemotherapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 3 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery At least 3 weeks since prior radiotherapy to the brain for brain metastases Prior radiotherapy to indicator lesions allowed if there is evidence of disease progression Recovered from prior radiotherapy No concurrent radiotherapy Surgery: At least 2 weeks since prior surgical procedure requiring general anesthesia and recovered
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Jen Hwu, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Krown SE, Hwu WJ, Menell JH, et al.: A phase II study of temozolomide (TMZ) and pegylated interferon α-2b (PGI) in the treatment of advanced melanoma. [Abstract] J Clin Oncol 22 (Suppl 14): A-7533, 718s, 2004.
Results Reference
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Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma

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