Clinical trial · Interventional
Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases
A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining whole-brain radiation therapy with thalidomide and temozolomide in treating patients who have newly diagnosed brain metastases.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall median survival
Secondary outcomes (6)
- measure
- Radiographic response rate as assessed by MRI and RECIST one-dimensional criterion at 1 month, 3 months, and every 3 months thereafter
- measure
- Median time to tumor progression
- measure
- Median time to neurologic response and progression
- measure
- Cause of death at median time
- measure
- Quality of life as assessed by FACT-BT, FACT-F, and Beck Depression Inventory at 1 month, 3 months, and every 3 months thereafter
- measure
- Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed extracranial primary malignancy or brain metastases * At least 1 brain metastasis with at least 1 unresected lesion that is measurable by contrast-enhanced MRI * No evidence of spinal drop metastases or spread to noncontiguous meninges * No lymphoma, small cell lung cancer, or germ cell tumor PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * At least 4 months Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin less than 1.5 mg/dL * SGPT and/or SGOT no greater than 2 times upper limit of normal Renal * Creatinine no greater than 1.5 mg/dL * BUN no greater than 25 mg/dL Other * Able to be regularly followed * No sensory neuropathy greater than grade 2 * No other major medical illnesses that would preclude study * No neurologic or psychiatric impairments that would preclude study * No active infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use at least 1 highly effective and 1 additional effective method of contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * No other concurrent chemotherapy during and for 4 weeks after study Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to head or neck * No prior stereotactic radiosurgery * Concurrent radiotherapy to extracranial sites of underlying malignancy allowed Surgery * Prior craniotomy allowed if completed within the past 10-28 days
References
Publications (0)
Data not yet available