Los Angeles,
California
90095
Purpose:
RATIONALE: Drugs used in chemotherapy, such as dacarbazine, use different ways to stop tumor
cells from dividing so they stop growing or die. Oblimersen may help dacarbazine kill more
tumor cells by making them more sensitive to the drug.
PURPOSE: This clinical trial is studying how well giving oblimersen together with
dacarbazine works in treating patients with advanced malignant melanoma that previously
responded to treatment with oblimersen and dacarbazine on clinical trial GENTA-GM301.
Study summary:
OBJECTIVES:
Primary
- Provide continuation therapy with oblimersen (G3139) and dacarbazine to patients with
advanced malignant melanoma who obtained response or stabilization of disease after
prior treatment with this therapy on GENTA-GM301.
Secondary
- Determine serious adverse events in patients treated with this regimen.
OUTLINE: This is a nonrandomized, open-label, multicenter, continuation study.
Patients receive oblimersen (G3139) IV continuously on days 1-5 and dacarbazine IV over 1
hour on day 5. Treatment repeats every 21 days for up to 8 courses in the absence of disease
progression or unacceptable toxicity. Patients who complete 8 courses of treatment may
receive additional courses at the discretion of the physician.
Patients are followed every 2 months for up to 2 years after initiation of GENTA-GM301
protocol.
PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.
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
Brief Title:
Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301
Official Title:
Continuation Protocol For G3139 (Bcl-2 Antisense Oligonucleotide) And Dacarbazine In Patients With Malignant Melanoma Who Responded To This Combination In Protocol GM301
Study Source:
National Cancer Institute (NCI)
Oversight Authority:
United States: Federal Government
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Overall Contact Information
Official Name: | John A. Glaspy, MD, MPH Principal Investigator Jonsson Comprehensive Cancer Center
|
Study Outcomes
There are no available Study Outcomes
Study Arms
There are no available Study Arms
Sample and Retention Information
There are no available Sample and Retention Information
Study References
There are no available Study References