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

Primary Purpose

Melanoma (Skin)

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
oblimersen sodium
dacarbazine
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, stage III melanoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 3, 2003
Last Updated
January 3, 2014
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00070343
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 Type
Interventional

2. Study Status

Record Verification Date
November 2004
Overall Recruitment Status
Unknown status
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma, stage III melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
oblimersen sodium
Intervention Type
Drug
Intervention Name(s)
dacarbazine

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A. Glaspy, MD, MPH
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6996
Country
United States

12. IPD Sharing Statement

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

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