ProMune™ (CPG 7909 Injection) With or Without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Melanoma
Both
Carcinoma, Melanoma
Trial Information
ProMune™ (CPG 7909 Injection) With or Without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study
Inclusion Criteria:
- Histologically or cytologically confirmed melanoma that is metastatic.
- Measurable disease according to the RECIST criteria.
- Karnofsky Performance Status of > 70.
Exclusion Criteria:
- Prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or
metastatic disease (except one course of adjuvant immunotherapy and/or adjuvant
chemotherapy other than DTIC).
- Suspected or known CNS metastases.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria.
Outcome Time Frame:
indeterminate
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
C023
NCT ID:
NCT00070642
Start Date:
December 2003
Completion Date:
December 2005
Related Keywords:
- Carcinoma, Melanoma
- Immunotherapy, skin cancer
- Carcinoma
- Melanoma
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