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Biological Therapy

Biological Therapy + Chemotherapy for Skin Cancer

Phase 1

Waitlist Available

Research Sponsored by St. Luke's Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hematopoietic: WBC at least 3,000/mm^3, Absolute neutrophil count greater than 1,500/mm^3, Platelet count at least 100,000/mm^3, Hemoglobin at least 10 g/dL, No coagulation disorder such as thrombophlebitis

Histologically or cytologically confirmed metastatic melanoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing the combination of a biological therapy with chemotherapy to see if it is more effective in treating metastatic melanoma than just the chemotherapy alone.

Who is the study for?

This trial is for adults with metastatic melanoma who have tried at least one treatment, can't undergo standard therapy due to illness, or chose not to. They must have good blood counts and organ function, no severe psychiatric issues or other cancers in the last 5 years, and cannot be pregnant. Participants need measurable disease by scans and a life expectancy over 3 months.Check my eligibility

What is being tested?

The study tests combining biological therapy (which boosts the immune system) with temozolomide chemotherapy to see if this mix is more effective against metastatic melanoma than previous treatments. It's an early-phase trial focusing on safety and how well patients respond.See study design

What are the potential side effects?

Possible side effects include typical reactions from immune stimulation such as flu-like symptoms, fatigue, skin reactions; and chemotherapy-related issues like nausea, hair loss, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood counts are within the required ranges and I don't have blood clotting disorders.

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My melanoma has spread and was confirmed by a lab test.

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My kidney function tests are within normal limits.

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I don't frequently vomit and can take pills without issue.

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I did not have severe bone marrow suppression for over 3 weeks from dacarbazine.

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I do not have any AIDS-related illnesses.

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My heart pumps well, and I don't have ongoing chest pain or uncontrolled heart issues.

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My liver function tests are within normal limits.

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I do not have any major illnesses besides my current condition.

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

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My lung function tests are normal, and I don't have an uncontrolled lung clot.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose at completion of study

Safety as measured by NCI common toxicity table at completion of study

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Luke's Medical CenterLead Sponsor

12 Previous Clinical Trials

208,473 Total Patients Enrolled

John P. Hanson, MDStudy ChairSt. Luke's Medical Center

7 Previous Clinical Trials

252 Total Patients Enrolled

Media Library

Aldesleukin (Biological Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00016055 — Phase 1

Skin Cancer Clinical Trial 2023: Aldesleukin Highlights & Side Effects. Trial Name: NCT00016055 — Phase 1

Aldesleukin (Biological Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00016055 — Phase 1

Frequently Asked Questions

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

Are there still opportunities to join this medical experiment?

"Clinicaltrials.gov has indicated that this particular trial, which had its inception on November 1st 2000 and was last updated September 19th 2013, is no longer enrolling participants. However, there are 757 other studies actively seeking enrollees at the moment."

Answered by AI

What measures have been taken to ensure the safety of this therapeutic approach?

"Our internal assessment of this treatment's safety is 1 due to the limited data generated during Phase 1 trials which suggest a lack of both efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma

2000. "Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00016055.

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