Clinical trial · Interventional
S0508: Thalidomide and Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
A Phase II Trial of Combination Thalidomide Plus Temozolomide in Patients With Metastatic Malignant Melanoma
NCT00104988CI-TRIAL-00007866completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide | Drug | Temozolomide | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thalidomide and Temozolomide
- 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.
- interventionNames
- Drug: temozolomide
- Drug: thalidomide
Primary outcomes (3)
- measure
- Progression-free survival at 6 months
- timeFrame
- 6 months after registration
- measure
- Objective response (confirmed and unconfirmed complete and partial responses)
- timeFrame
- Week 9, every 8 weeks thereafter until progression
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapyReferences
Publications (1)
- RESULTClark JI, Moon J, Hutchins LF, Sosman JA, Kast WM, Da Silva DM, Liu PY, Thompson JA, Flaherty LE, Sondak VK. Phase 2 trial of combination thalidomide plus temozolomide in patients with metastatic malignant melanoma: Southwest Oncology Group S0508. Cancer. 2010 Jan 15;116(2):424-31. doi: 10.1002/cncr.24739. PMID 19918923