Advanced Melanoma
Conditions
Keywords
bcl-2, CFR, DTIC, ECOG, EMEA, MedDRA, NCI CTC, SAE
Brief summary
This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense
Interventions
DRUGGenasense followed by DTIC; then DTIC alone
Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
DRUGDTIC alone; then Genasense followed by DTIC
Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2
Sponsors
Genta Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Metastatic Stage IV disease, or Stage III disease that is not surgically resectable * ECOG Performance Status of 0, 1, or 2 * Life expectancy of at least 12 weeks * Adequate venous access * Agreement to practice effective method of birth control
Exclusion criteria
* Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy * Significant medical disease * Known hypersensitivity to phosphorothioate-containing oligonucleotides * Known hypersensitivity to DTIC * Pregnancy/Lactation
Outcome results
None listed