Status:
COMPLETED
Temozolomide, Thalidomide, and Lomustine in Treating Patients With Unresectable Stage III or Stage IV Melanoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Melanoma
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer b...
Detailed Description
OBJECTIVES: Primary * Determine the antitumor activity of temozolomide, thalidomide, and lomustine, in terms of objective response rate, in patients with unresectable stage III or stage IV melanoma....
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic malignant melanoma
- Unresectable stage III OR stage IV disease
- Ocular, mucosal, and cutaneous melanoma allowed
- Measurable disease
- Indicator lesions within a prior radiotherapy field must have recent evidence of disease progression
- Indicator lesions must be distinct from the surgical and/or radiation changes induced by prior local therapies
- No more than 2 symptomatic hemorrhagic lesions in the brain
- No hemorrhagic lesion(s) greater than 1 cm in diameter
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Karnofsky 80-100%
- Life expectancy
- Not specified
- Hematopoietic
- Absolute granulocyte count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Hepatic
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- SGOT and SGPT no greater than 2 times ULN
- Alkaline phosphatase no greater than 2 times ULN
- Lactic dehydrogenase no greater than 2 times ULN
- Renal
- Creatinine no greater than 2 mg/dL
- 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 congestive heart failure
- No ventricular arrhythmia
- No uncontrolled arrhythmia
- Gastrointestinal
- No frequent vomiting
- No other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 4 weeks after study participation
- HIV negative
- No AIDS-related illness
- No serious infection requiring IV antibiotics
- No other uncontrolled medical illness that would preclude study participation
- No other malignancy within the past 2 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer meeting all of the following criteria:
- Detected incidentally at transurethral resection of the prostate (TURP)
- Comprises less than 5% of resected tissue
- Prostate-specific antigen normal since TURP
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- At least 3 weeks since prior immunotherapy or biologic therapy
- No concurrent immunotherapy
- Chemotherapy
- No prior systemic chemotherapy for melanoma
- No other concurrent chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior focused radiotherapy for brain metastases
- At least 3 weeks since prior radiosurgery
- At least 4 weeks since prior whole brain radiotherapy
- At least 3 weeks since prior interstitial brachytherapy
- No concurrent radiotherapy
- Surgery
- See Disease Characteristics
- At least 3 weeks since prior surgery for brain metastases
- At least 3 weeks since prior surgery requiring general anesthesia
- Other
- Recovered from all prior therapies
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00072345
Start Date
July 1 2003
Last Update
January 18 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021