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A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Intraocular Melanoma, Melanoma (Skin)

Thank you

Trial Information

A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Wen-Jen Hwu, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

03-084

NCT ID:

NCT00072345

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • 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
  • Uveal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021