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Alkylating agent

Oblimersen + Dacarbazine for Melanoma

N/A
Waitlist Available
Led By John A. Glaspy, MD, MPH
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Performance status: ECOG 0-2
Hepatic: Bilirubin no greater than 1.5 times upper limit of normal, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing whether combining oblimersen with dacarbazine is more effective than dacarbazine alone in treating patients with advanced melanoma.

Who is the study for?
This trial is for patients with advanced malignant melanoma who saw benefits from previous treatment in the GENTA-GM301 trial. They must have measurable disease, stable blood counts and organ function, no history of certain diseases like chronic hepatitis or active malignancy, not be pregnant or nursing, able to use an infusion pump, and have a performance status allowing daily activities.Check my eligibility
What is being tested?
The study tests how well oblimersen enhances dacarbazine's effectiveness against advanced malignant melanoma in patients who responded to this combination before. It aims to see if making cancer cells more sensitive to chemotherapy improves outcomes.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response, fatigue, nausea and vomiting due to chemotherapy. Oblimersen may also cause flu-like symptoms and injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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My liver functions are within acceptable ranges and I don't have chronic hepatitis or cirrhosis.
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I do not have any current infections.
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I can manage an infusion pump by myself.
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My melanoma is confirmed to be advanced through testing.
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I do not have uncontrolled brain cancer spread.
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My heart condition is stable with no severe symptoms or recent issues.
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My diabetes is under control.
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My cancer cannot be removed by surgery or has spread to other parts of my body.
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My cancer can be measured or seen on tests.
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My blood counts meet the required levels for treatment.
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My kidney function is within the required range.
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I do not have an active autoimmune disease.
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I do not have any major health issues.
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I have not had severe side effects from oblimersen or dacarbazine.
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I do not have seizures that my medication cannot control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
358 Previous Clinical Trials
26,076 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,646 Total Patients Enrolled
John A. Glaspy, MD, MPHPrincipal InvestigatorJonsson Comprehensive Cancer Center
7 Previous Clinical Trials
135 Total Patients Enrolled

Media Library

Dacarbazine (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT00070343 — N/A
Skin Cancer Research Study Groups:
Skin Cancer Clinical Trial 2023: Dacarbazine Highlights & Side Effects. Trial Name: NCT00070343 — N/A
Dacarbazine (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00070343 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any open slots for the clinical trial?

"Clinicaltrials.gov reveals that this trial, originally posted in August 2003 and last updated on March 2014, is no longer recruiting participants. However, there are currently 761 other studies looking for patients at the present moment."

Answered by AI
~16 spots leftby Mar 2025