Melanoma Clinical Trial

Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Melanoma

Study ID:

NCT00070343

Recruitment Status:

Unknown status

Sponsor:

Jonsson Comprehensive Cancer Center

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There is 1 Location for this study

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Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Study ID:

NCT00070343

Recruitment Status:

Unknown status

Sponsor:


Jonsson Comprehensive Cancer Center

How clear is this clinincal trial information?

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