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Thalidomide in Treating Patients With Extensive-Stage Small Cell Lung Cancer



Thalidomide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

For Condition: extensive stage small cell lung cancer
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have extensive-stage small cell lung cancer that has responded to previous chemotherapy.
Details: OBJECTIVES: - Determine the effect of thalidomide on time to disease progression and survival in patients with extensive-stage small cell lung cancer who achieve a complete or partial response to induction chemotherapy. - Determine the toxicity of this drug in these patients. OUTLINE: This is an open-label study. Patients receive oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within approximately 18 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of extensive-stage small cell lung cancer - Complete or partial response after 4-6 courses of induction chemotherapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 2 months Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 effective methods of contraception for at least 4 weeks before, during, and for at least 4 weeks after study - No greater than grade 1 peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AfshinDowlati,  Study Chair,  Ireland Cancer Center

Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit,  Michigan,  48202
United States
Recruiting Robert  Chapman 313-916-1850

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106-5065
United States
Recruiting Afshin  Dowlati 216-844-1228


Additional Information:
Study ID Numbers:
  CDR0000269344;  CWRU-1502,CELGENE-CWRU-1502
Study Start Date: 
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053300

Other Extensive Stage Small Cell Lung Cancer Studies:
1. Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer

2. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Cancer.

3. Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer

4. Combination Chemotherapy Plus Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

5. Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

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Thalidomide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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