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CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma Clinical research trials and CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma. CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma clinical trial. Participants oftentimes recieve the most expert healthcare available for their CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma  CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma
CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma
For Condition: Recurrent Melanoma,Stage 4 Melanoma
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: CC-5013 may stop the growth of melanoma by stopping blood flow to the tumor. It is not yet known which dose of CC-5013 is more effective in treating stage IV melanoma. PURPOSE: Randomizedphase II/III trial to compare the effectiveness of two different doses of CC-5013 in treating patients who have progressive or relapsed stage IV melanoma.
Details: OBJECTIVES: - Compare the efficacy of 2 dosing schedules of CC-5013, in terms of overall survival, in patients with previously treated metastatic malignant melanoma that is refractory or has relapsed. - Compare the safety of these dose schedules, in terms of type, frequency, and severity of adverse events and relationship of adverse events to study therapy, in these patients. - Compare the time to progression and response rate of patients treated with these dose schedules. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to ECOG performance status (0 and 1 vs 2), metastatic sites of disease (M1 vs M2 vs M3), and lactic dehydrogenase (normal vs elevated). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive a lower dose of oral CC-5013 and oral placebo once daily on days 1-28. - Arm II: Patients receive a higher dose of oral CC-5013 and oral placebo once daily on days 1-21, then receive 2 oral placebos once daily on days 22-28. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 274 patients (137 patients per treatment arm) will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic malignant melanoma - Stage IV disease - Relapsed or refractory to standard therapy for metastatic disease (i.e., dacarbazine, interleukin-2, interferon alfa, and/or interferon beta) - At least 1 measurable lesion - No newly diagnosed brain metastases within the past 4 weeks PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - AST and ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present) - No hepatitis A, B, or C Renal - Creatinine no greater than 1.5 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No active brain disease within the past 4 weeks - No known hypersensitivity to thalidomide - No development of erythema nodosum (if characterized by a desquamating rash while taking thalidomide or similar drugs) - No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent - No other condition, including laboratory abnormalities, that would preclude study participation or confound interpretation of results PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior CC-5013 - No concurrent thalidomide - No concurrent sargramostim (GM-CSF) Chemotherapy - See Disease Characteristics Endocrine therapy - At least 4 weeks since prior hormonal therapy Radiotherapy - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - At least 4 weeks since other prior cancer therapy - More than 4 weeks since prior experimental drugs or therapies - No other concurrent anticancer agents or treatment - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnGlaspy, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting John Glaspy 310-825-1274
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Wen-Jen Hwu 212-639-5096
Additional Information:
Study ID Numbers: CDR0000301590; UCLA-0210051,MSKCC-03026,CELGENE-CDC-501-MEL-001
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060281
Other Stage 4 Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Stage IV Melanoma
2. Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma
3. Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
4. Imatinib Mesylate in Treating Patients With Metastatic Melanoma
5. Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Kidney Cancer or Malignant Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma
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