Clinical trial · Interventional
Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301
Continuation Protocol For G3139 (Bcl-2 Antisense Oligonucleotide) And Dacarbazine In Patients With Malignant Melanoma Who Responded To This Combination In Protocol GM301
NCT00070343CI-TRIAL-00013321unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dacarbazine | Drug | Dacarbazine | ALIAS |
| oblimersen sodium | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.