Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma Clinical research trials and Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma clinical trial. Test subjects typically receive the most expert healthcare available for their Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

Home > "V" Clinical Trials Conditions > Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma

Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma



Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma

For Condition: stage 3 melanoma,Recurrent Melanoma,Stage 4 Melanoma
Status: No longer recruiting
Sponsor(s): Genzyme ,
Synopsis: RATIONALE: Vaccines made from a person's white blood cells combined with melanoma antigens may make the body build an immune response to tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for stage III or stage IV melanoma. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have stage III or stage IV melanoma that cannot be surgically removed.
Details: OBJECTIVES: I. Evaluate the safety, dose-limiting toxicity, and maximum tolerated dose of autologous dendritic cells transduced with adenoviruses encoding the MART-1 and gp100 melanoma antigens with or without interleukin-2 in patients with stage III or IV melanoma. II. Evaluate the cellular response and efficacy of these regimens in this patient population. PROTOCOL OUTLINE: This is a dose-escalation study. Patients are sequentially assigned to one of three dose levels. Patients receive modified autologous dendritic cells subcutaneously on day 1 with or without interleukin-2 IV on days 4-19. Treatment continues every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of modified dendritic cells with or without interleukin-2 until the maximum tolerated dose (MTD) for each regimen is reached. The MTD is defined as the dose below that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 24-36 patients will be accrued for this study within 1 year.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage III or IV metastatic melanoma; Unresectable disease for which no other therapy exists - Measurable or evaluable disease by clinical or radiographic evaluation - Metastatic tumor tissue expressing both gp100 and MART-1 - No uncontrolled or progressive CNS involvement --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunotherapy with vaccines directed at MART-1 or gp100 melanoma antigens; Prior interleukin-2 or interferon therapy allowed - Chemotherapy: At least 4 weeks since prior chemotherapy and recovered; No concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered - Surgery: At least 4 weeks since prior surgery (except study biopsies) and recovered - Other: At least 4 weeks since prior experimental therapy and recovered; At least 4 weeks since prior immunosuppressive drugs and recovered; No other concurrent experimental therapy or anti-cancer drugs; No concurrent immunosuppressive therapy --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; No clinically significant hematologic disorder - Hepatic: Bilirubin less than 2.0 mg/dL; No clinically significant hepatic disease; Hepatitis B surface antigen negative - Renal: Creatinine less than 2.0 mg/dL; No clinically significant renal disease - Cardiovascular: No clinically significant cardiac disease - Other: Not pregnant or nursing; Fertile patients must use effective contraception; Negative pregnancy test; HIV-1 and HIV-2 negative; HTLV-1 negative; No significant psychiatric disorder that would prevent compliance; No underlying condition that would preclude study therapy; No autoimmune disease or other major immune system illness; No active infection requiring parenteral antibiotic therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AmyBock,  Study Chair,  Genzyme

U.S. Oncology
Houston,  Texas,  77060
United States
 

Dana-Farber Cancer Institute
Boston,  Massachusetts,  02115
United States
 


Additional Information:
Study ID Numbers:  CDR0000067245;  GENZ-ML98-0501,DFCI-98258
Study Start Date: March 1999
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004025

Other Stage 3 Melanoma Studies:
1. Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma

2. Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma

3. Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

4. Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma

5. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer

Related Studies:

Other stage 3 melanoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials

Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
Modify your Search

  Other stage 3 melanoma Clinical Trials
  Other Texas Clinical Trials
  Other Houston Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103