Status:
COMPLETED
Study of MDX-010 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I, open-label, multicenter, pharmacokinetic study of MDX-010 in up to 90 evaluable subjects with surgically unresectable malignant melanoma.
Detailed Description
Group A: Six to 12 subjects will be treated with transfectoma-derived MDX-010 at 2.8 or 5 mg/kg/dose, or with hybridoma-derived MDX-010 at 3 mg/kg/dose administered on Days 1, 57, and 85. The 2.8, 3, ...
Eligibility Criteria
Inclusion
- Subject must have read, understood, and provided written informed consent and authorization in compliance with the Health Insurance Portability and Accountability Act (HIPAA) afer the nature of the study has been fully explained.
- Subject must be at least 18 years of age with a histologic diagnosis of unresectable Stage III or IV malignant melanoma (may include mucosal melanoma). Subjects with either stable or progressive malignancy will be permitted in the study. Classification of stable or progressive disease, to be recorded for all subjects, will be defined by the Response Evaluation Criteria in Solid Tumors (RECIST), as detailed in Appendix 3 and determined since last melanoma treatment. Subjects must have at least 1 site of measurable disease.
- At least 4 weeks since treatment (surgery, chemotherapy, radiation, or immuno- therapy) for melanoma and recovered from any serious toxicity experienced during treatment.
- Life expectancy of at least 18 weeks.
- Karnofsky Performance Status of at least 70%
- Screening laboratory values must meet the following criteria:
- WBC ≥2500/μL
- ANC ≥1500/μL
- Platelets ≥100 x 10'/μL
- Hematocrit ≥30%
- Hemoglobin ≥10 g/dL
- Creatinine ≤2 mg/dL
- AST ≤2 x ULN\*
- Bilirubin ≤1.0 x ULN\*, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
- HIV negative
- HBsAg negative
- anti-HCV nonreactive. If reactive, subject must have a negative HCV RNA qualitative PCR.
- Unless definitely attributable to disease.
Exclusion
- Any prior malignancy except for the following: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer from which the subject has been disease-free for at least 5 years
- History of autoimmune disease (including uveitis and autoimmune inflammatory eye disease) prior to entrance into the study.
- Active infection requiring therapy, chronic active HBV or HCV, or confirmed reactivity with HIV tests.
- Tetanus booster immunization within 2 months of initial screening procedures, or a history of anaphylaxis or severe local reaction to the tetanus vaccine.
- Pregnant or nursing: it is not known what effect MDX-010 could have on the developing immune system of the fetus or infant, therefore, exposure in utero or via breast milk will not be allowed.
- Any underlying medical condition which, in the opinion of the principal investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events.
- Any concurrent medical condition requiring the use of systemic or topical corticosteroids or the use of immunosuppressive agents (e.g. cyclosporine and its analog, or chemotherapy agents). All corticosteroid use must have been discontinued at least 4 weeks prior to trial entry.
- Prior treatment with MDX-010 or any other anti-CTLA-4 monoclonal antibody.
- Evidence or history of significant cardiac, pulmonary, hepatic, renal, psychiatric or gastrointestinal disease that would make the administration of MDX-010 unsafe.
- Concurrent treatment with chemotherapy or other immunotherapy regimens (must be completed at least 4 weeks before Screening).
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00729950
Start Date
July 1 2003
End Date
June 1 2007
Last Update
April 26 2010
Active Locations (4)
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1
Arizona Cancer Center
Tucson, Arizona, United States, 85724-5024
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
Piedmont Oncology Specialists
Charlotte, North Carolina, United States, 28207
4
Providence Portland Medical Center
Portland, Oregon, United States, 97213