Continuation Protocol For G3139 (Bcl-2 Antisense Oligonucleotide) And Dacarbazine In Patients With Malignant Melanoma Who Responded To This Combination In Protocol GM301
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced malignant melanoma
- Unresectable or metastatic disease
- Previously enrolled on GENTA-GM301 protocol
- Complete or partial objective response or stable disease after completion of 8
courses of oblimersen (G3139) and dacarbazine on arm II of GENTA-GM301
- Measurable or evaluable disease
- No uncontrolled brain metastases or leptomeningeal disease
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3*
- Platelet count at least 100,000/mm^3*
- Hemoglobin at least 8 g/dL* NOTE: *Hematopoietic growth factor or transfusion
independent
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- Albumin at least 2.5 g/dL
- PTT no greater than 1.5 times ULN
- PT no greater than 1.5 times ULN OR
- INR no greater than 1.3
- No history of chronic hepatitis or cirrhosis
Renal
- Creatinine no greater than 1.5 times ULN OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No uncontrolled congestive heart failure
- No active symptoms of coronary artery disease, defined as uncontrolled arrhythmias or
recurrent chest pain despite prophylactic medication
- No New York Heart Association class III or IV heart disease
- No cardiovascular signs and symptoms grade 2 or greater within the past 4 weeks
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other significant medical disease
- No uncontrolled seizure disorder
- No active infection
- No uncontrolled diabetes mellitus
- No active autoimmune disease
- No known hypersensitivity to phosphorothioate-containing oligonucleotides or
dacarbazine
- No intolerance to prior oblimersen and dacarbazine, including discontinuation of
protocol therapy due to 1 or more adverse events
- HIV negative
- Satisfactory venous access for a 5-day continuous infusion
- Intellectually, emotionally, and physically able to maintain an ambulatory infusion
pump
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior biologic therapy, immunotherapy, cytokine therapy, or
vaccine therapy and recovered
- No concurrent anticancer biologic therapy
Chemotherapy
- See Disease Characteristics
- No other concurrent anticancer chemotherapy
Endocrine therapy
- No concurrent chronic corticosteroids (average dose of at least 20 mg/day of
prednisone or equivalent)
Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent anticancer radiotherapy
Surgery
- At least 4 weeks since prior major surgery and recovered
Other
- At least 4 weeks since other prior therapy and recovered
- More than 3 weeks since prior experimental therapy (except for GENTA-GM301 protocol)
- No intervening systemic therapy for melanoma since completion of GENTA-GM301 protocol
therapy
- No other concurrent anticancer therapy, including investigational therapy
- No concurrent immunosuppressive drugs
- No concurrent anticoagulation therapy
- Concurrent warfarin (1 mg/day) for central line prophylaxis is allowed