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Continuation Protocol For G3139 (Bcl-2 Antisense Oligonucleotide) And Dacarbazine In Patients With Malignant Melanoma Who Responded To This Combination In Protocol GM301


N/A
N/A
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

Continuation Protocol For G3139 (Bcl-2 Antisense Oligonucleotide) And Dacarbazine In Patients With Malignant Melanoma Who Responded To This Combination In Protocol GM301


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

John A. Glaspy, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000331927

NCT ID:

NCT00070343

Start Date:

August 2003

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • stage III melanoma
  • Melanoma

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781