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A Phase I/II Study of Temozolamide and Thalidomide in the Treatment of Advanced Melanoma

Phase 1/Phase 2
18 Years
Not Enrolling
Intraocular Melanoma, Melanoma (Skin)

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Trial Information

A Phase I/II Study of Temozolamide and Thalidomide in the Treatment of Advanced Melanoma


- Determine the maximum tolerated dose (MTD) of temozolomide using an extended continuous
schedule in combination with thalidomide in patients with advanced melanoma.

- Determine the response rate to this combination using an extended continuous schedule
at the MTD in 30 patients who have advanced metastatic melanoma without brain
metastases and in 15 patients who have metastatic melanoma in the brain.

- Further characterize the safety and toxicity of this combination in these patients.

OUTLINE: This is a dose escalation study of temozolomide (phase I) followed by a response
rate determination study (phase II).

Patients receive oral temozolomide daily for 6 weeks followed by 2-4 weeks of rest. Patients
receive oral thalidomide daily for the entire 8-10 week course. Treatment continues in the
absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose limiting toxicities. Once the MTD is determined, additional
patients are accrued to receive treatment with temozolomide and thalidomide at the
recommended phase II dose.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for phase I and then an
additional 45 patients (15 with CNS disease, 30 without CNS disease) will be accrued for
phase II of this study within 18 months.

Inclusion Criteria


- Histologically confirmed metastatic malignant melanoma that is considered

- Stage III or IV ocular, mucosal, or cutaneous melanoma

- Measurable disease

- No CNS disease (phase I only)



- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified


- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 150,000/mm^3


- 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


- Creatinine no greater than 1.5 times ULN


- No history of active angina

- No myocardial infarction within past 6 months

- No history of significant ventricular arrhythmia requiring medication with


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for 4 weeks
before and after study

- No frequent vomiting or medical condition that could interfere with oral medication
intake (e.g., partial bowel obstruction)

- No preexisting neurotoxicity grade 2 or greater

- No serious concurrent infections treated with antibiotics

- No nonmalignant medical illnesses that are uncontrolled or whose control may be
jeopardized by the complications of this study

- No psychiatric disorders that would preclude study compliance

- No other medical condition or reason that would preclude study

- No other malignancy within the past 2 years except:

- Nonmelanoma skin cancer

- Carcinoma in situ of the cervix

- History of T1a or b prostate cancer detected incidentally at TURP and comprising
less than 5% of resected tissue with PSA normal since TURP

- No AIDS related illness

- HIV negative


- Recovered from prior therapy

Biologic therapy:

- At least 4 weeks since prior biologic therapy

- At least 4 weeks since prior immunotherapy

- No concurrent immunotherapy


- No prior systemic chemotherapy for metastatic melanoma

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified


- At least 4 weeks since prior radiotherapy, interstitial brachytherapy, or

- At least 3 weeks since prior radiotherapy to the brain if brain metastases from

- Prior radiotherapy to only indicator lesion allowed provided recent evidence of
disease progression at that site

- No concurrent radiotherapy


- At least 2 weeks since prior surgery requiring general anesthesia

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Wen-Jen Hwu, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 1999

Completion Date:

August 2004

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • iris melanoma
  • ciliary body and choroid melanoma, small size
  • ciliary body and choroid melanoma, medium/large size
  • extraocular extension melanoma
  • recurrent intraocular melanoma
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma
  • Uveal Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021