Temozolomide, Thalidomide, and Lomustine in Treating Patients With Unresectable Stage III or Stage IV Melanoma
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ClinicalTrials.gov Identifier: NCT00072345 |
Recruitment Status :
Completed
First Posted : November 6, 2003
Last Update Posted : January 18, 2013
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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 by stopping blood flow to the tumor. Combining temozolomide and thalidomide with lomustine may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide with lomustine in treating patients who have unresectable stage III or stage IV melanoma.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intraocular Melanoma Melanoma (Skin) | Drug: lomustine Drug: temozolomide Drug: thalidomide | Phase 2 |
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.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the duration of response and overall survival of patients treated with this regimen.
OUTLINE: Patients receive oral temozolomide on days 1-42, oral thalidomide on days 1-56, and oral lomustine on days 1 and 29. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 2 years.
Study Type : | Interventional (Clinical Trial) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma |
Study Start Date : | July 2003 |
Actual Primary Completion Date : | August 2004 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed metastatic malignant melanoma
- Unresectable stage III OR stage IV disease
- Ocular, mucosal, and cutaneous melanoma allowed
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072345
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Wen-Jen Hwu, MD, PhD | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00072345 |
Other Study ID Numbers: |
03-084 P30CA008748 ( U.S. NIH Grant/Contract ) MSKCC-03084 |
First Posted: | November 6, 2003 Key Record Dates |
Last Update Posted: | January 18, 2013 |
Last Verified: | January 2013 |
stage III melanoma stage IV melanoma recurrent melanoma iris melanoma |
ciliary body and choroid melanoma, medium/large size ciliary body and choroid melanoma, small size extraocular extension melanoma recurrent intraocular melanoma |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Thalidomide Temozolomide Lomustine Antineoplastic Agents, Alkylating Alkylating Agents |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |