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A Phase II Trial of Combination Thalidomide Plus Temozolomide in Patients With Metastatic Malignant Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

A Phase II Trial of Combination Thalidomide Plus Temozolomide in Patients With Metastatic Malignant Melanoma


- Determine the 6-month progression-free survival of patients with unresectable stage IV
malignant cutaneous melanoma treated with thalidomide and temozolomide.

- Determine the objective response (confirmed and unconfirmed complete response and
partial response) in patients with measurable disease treated with this regimen.

- Determine the overall survival of patients treated with this regimen.

- Determine the qualitative and quantitative toxic effects of this regimen in these

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily on days 1-56 and temozolomide once daily on
days 1-42. Courses repeat every 56 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed at week 9, every 2 months until
disease progression, and then every 6 months until 3 years from study entry.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14 months.

Inclusion Criteria


- Histologically confirmed malignant cutaneous melanoma

- Unresectable, stage IV disease

- Unknown primary allowed

- Measurable or non-measurable disease

- If all known sites of disease are within a previously irradiated port, disease
progression must be clearly demonstrated

- No brain metastases by CT scan or MRI within the past 42 days

- Prior brain metastasis allowed provided both of the following criteria are met:

- Completely resected and free of disease

- Treated with whole brain radiotherapy and completed treatment at least 28
days ago



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL (transfusions allowed)


- Bilirubin ≤ 3 times upper limit of normal (ULN)

- SGOT or SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)


- Creatinine ≤ 1.5 times ULN


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception for 4 weeks before,
during, and for 4 weeks after study participation

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in complete remission

- No history of allergic reaction to dacarbazine


Biologic therapy

- No prior thalidomide for stage IV disease

- At least 28 days since prior biological therapy

- At least 28 days since prior immunotherapy

- At least 28 days since prior adjuvant interferon alfa


- No prior temozolomide or dacarbazine for stage IV disease

- At least 28 days since prior chemotherapy

Endocrine therapy

- At least 28 days since prior hormonal therapy


- See Disease Characteristics

- At least 28 days since prior radiotherapy


- See Disease Characteristics

- At least 28 days since prior surgery for primary and stage IV disease


- No more than 1 prior systemic therapy regimen for stage IV disease

- At least 28 days since other prior systemic therapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 6 months

Outcome Time Frame:

6 months after registration

Safety Issue:


Principal Investigator

Joseph I. Clark, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Loyola University


United States: Federal Government

Study ID:




Start Date:

June 2005

Completion Date:

August 2009

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • Melanoma



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