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Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma Clinical research trials and Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma medical trials take place in many of places 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma. Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma clinical trial. Test subjects typically obtain the finest healthcare available for their Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma  Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma
Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma
For Condition: Malignant Melanoma
Status: No longer recruiting
Sponsor(s): ImClone Systems , Memorial Sloan-Kettering Cancer Center
Synopsis: Up to 24 patients with stage III or stage IV melanoma will be enrolled. Patients who are currently disease-free but at high risk for relapse are also eligible. Patients will receive vaccinations of gp75 at assigned dose levels. Patients who exhibit serologic and stable/clinical response are eligible to receive booster vaccinations. Patients will be evaluated for safety and efficacy throughout the duration of the study. In this study, the optimal biologically effective dose is defined as the lowest dose of gp75 that results in the production of anti-gp75 antibodies.
Details: This study is designed to evaluate the safety and feasibility of intramuscular vaccination with gp75 DNA in patients with stage III or IV melanoma. Secondary objectives are to observe the patient for any evidence of anti-tumor response and to establish the optimal biologically effective dose. Up to 24 evaluable patients with stage III or IV metastatic melanoma or with stage III melanoma, currently disease-free, but at high risk for recurrence will be enrolled. Patients will be be enrolled into an assigned dose group and will receive five vaccinations of gp75. In order for dose escalation to proceed, only one patient in the current dose group may have demonstrated a dose limiting toxicity (DLT). If a second patient experiences such toxicity then both patients will move down to the previous dose level, and the previous dose level will be considered to be the MTD. If no DLTs are encountered, patients will continue on study at the assigned dose level. Any patient experiencing a DLT will not receive further vaccination until the toxicity has resolved. Patients exhibiting both serological and stable/clinical response after receiving the fifth vaccination will be eligible to receive booster vaccinations. An additional patient will be accrued to the dose level for every patient that progresses prior to the fifth vaccination.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Age 18 years or older with Karnofsky performance status of 80 or greater, with a diagnosis of AJCC stage III or IV malignant melanoma. Patients free of disease after surgical resection of stage III or IV disease, but at high risk (defined as a primary tumor > 4 mm, satellite or in-transit lesions, 1 or more positive lymph nodes or distant metastases) for recurrence are also eligible. No more than five sites of metastatic disease permitted. - Patient has given signed informed consent - Patient has had surgery for their melanoma at least 6 months prior to study entry, or has had prior interferon therapy, or developed unacceptable toxicities to interferon therapy, or has a pre-existing condition(s) that precludes the patient from receiving interferon treatment - Patient has completed any prior irradiation, chemotherapy, or systemic immunotherapy (interferon-alpha, or interleukin-2) at least 30 days prior to study entry - Adequate hematologic function: platelet count ³ 100,000/mm3; WBC level ³ 3,000/mm3 - Normal serum LDH and a serum creatinine level < 2.0 mg/dL - Agrees to use effective contraception if procreative potential exists Exclusion Criteria: - Patient has stage III disease otherwise eligible to receive standard of care melanoma therapy. - Patient has a medical condition or uses medication (eg, corticosteroids) that might make it difficult for the patient to complete the full course of treatments or to respond immunologically to them, in the opinion of the investigator. - The patient has received irradiation, chemotherapy, or systemic immunotherapy (interferon-alpha, or interleukin-2) within 30 days prior to study entry - Patient is pregnant (confirmed by serum beta human chorionic gonadotropin [bHCG], if applicable) or is breast feeding. - Patient has received an investigational agent within 30 days of study entry - Patient has received prior cancer vaccine therapy - Patient has evidence of central nervous system (CNS) metastasis - The patient has evidence of an ocular abnormality, as detected by a slit-lamp ophthalmologic examination, within 4 weeks prior to study entry
Total Enrollment: 24
Location and Contact Information:
MSKCC Memorial Hospital
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CP09-0001;
Study Start Date: March 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034554
Other Malignant Melanoma Studies:
1. Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma
2. Vaccine Therapy for Patients with Stage IV Melanoma
3. Phase II Trial of Allovectin-7® for Metastatic Melanoma
4. Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma
5. Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb
Related Studies:
Other Malignant Melanoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma
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