S0508: Thalidomide and Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Drug: thalidomide; Drug: temozolomide

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00104988

CDR0000412048

S0508 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Thalidomide may stop the growth of melanoma by blocking blood flow to the tumor. It may also stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving thalidomide together with temozolomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving thalidomide together with temozolomide works in treating patients with stage IV melanoma that cannot be removed by surgery.

Full description

OBJECTIVES:

• 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 patients.

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 g/dL (transfusions allowed)

Hepatic

• Bilirubin ≤ 3 times upper limit of normal (ULN)
• SGOT or SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)

Renal

• Creatinine ≤ 1.5 times ULN

Other

• 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy

• 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

Radiotherapy

• See Disease Characteristics
• At least 28 days since prior radiotherapy

Surgery

• See Disease Characteristics
• At least 28 days since prior surgery for primary and stage IV disease

Other

• No more than 1 prior systemic therapy regimen for stage IV disease
• At least 28 days since other prior systemic therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Thalidomide and Temozolomide

Experimental group

Description:

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.

Treatment:

Drug: temozolomide

Drug: thalidomide