Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases

NCT00049361 | Completed Phase 2

• 3 other identifiers: REBACDR0000258057CCCWFU-91102NCI-5883
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

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

Unspecified Adult Solid Tumor, Protocol Specific; Brain and Central Nervous System Tumors

Keywords

adult tumors metastatic to brain; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Overall median survival

Secondary Outcomes (6)

• Radiographic response rate as assessed by MRI and RECIST one-dimensional criterion at 1 month, 3 months, and every 3 months thereafter

• Median time to tumor progression

• Median time to neurologic response and progression

• Cause of death at median time

• Quality of life as assessed by FACT-BT, FACT-F, and Beck Depression Inventory at 1 month, 3 months, and every 3 months thereafter

Interventions

temozolomide DRUG

thalidomide DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1030, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms

Interventions

Temozolomide; Thalidomide; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• Volker W. Stieber, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2004
• Primary Completion: December 7, 2004
• Study Completion: December 7, 2004
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

US (5)